CourseManual_2013-2014_v2 (1)

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course manualedition

Collaboration:

A PHARMATRAIN CENTRE OF EXCELLENCE

Code Module Title Date Location

M01Introductory Module: Product Research and Development Process

October 3-5, 2013

University of Aveiro

O09 Quality Management and InspectionsOctober 17-19, 2013

INFARMED, Lisbon

M02Non-Clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery to First in Humans

October 31 to November 2, 2013


O04 Managing an R&D ProjectNovember 14-16. 2013


M03Exploratory & Confirmatory Clinical Development: Clinical Pharmacology

November 28-30, 2013

INFARMED, Lisbon

M04 Clinical Trials: Clinical DevelopmentDecember 12-14, 2013

INFARMED, Lisbon

O11Ethics Is Clinical Research: Practical Approach to Ethical & Legal Aspects of Clinical Trials

January 9-11, 2014

INFARMED, Lisbon

O12Principles and Practices of Medical Device Development

January 23-25, 2014


M05Regulatory Affairs, Drug Safety & Pharmacovigilance I: Medicines Regulation / Regulatory Affairs

February 6-8, 2014

INFARMED, Lisbon

M06Regulatory Affairs, Drug Safety & Pharmacovigilance II: Drug Safety And Pharmacovigilance

February 20-22, 2014

INFARMED, Lisbon

O07 Medical AffairsMarch 6-8, 2014

INFARMED, Lisbon

M07Systematic Review and Meta-Analysis: Clinical Data Management And Analysis

March 20-22, 2014


M09Healthcare Marketplace & Economics of Healthcare II: Health Economics

April 3-5, 2014

INFARMED, Lisbon

O08 Statistics Applied to Clinical ResearchApril 10-12, 2014


M08Healthcare Marketplace & Economics of Healthcare I: Healthcare Marketplace

May 8-10, 2014


O05 Informatics in Medicine and Clinical ResearchMay 22-24, 2014


MODULES SCHEDULEedition

To Prof. Dr. Fritz R. Bühler, a great source of inspiration

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CONTENTS

CONTACTS

OVERVIEW

MISSION AND AIMS

PROGRAMME STRUCTURE

TEACHING STAFF

DETAILS OF EACH CURRICULAR UNIT

MANDATORY CURRICULAR UNITS

OPTIONAL CURRICULAR UNITS

ADMINISTRATIVE MATTERS

ADMISSION REQUIREMENTS

TEACHING METHODS

CURRICULAR UNIT ASSESSMENT

MASTER THESIS

PROGRAMME MANAGEMENT

PROGRAMME EVALUATION

OTHER INFORMATION

course manualedition

V2, 01 Oct 2013

Collaboration:

CONTACTSDIRECTOR: Luis Almeida, MD, PhD: [email protected]

DEPUTY DIRECTOR: Bruno Gago, PharmD, PhD: [email protected]

ASSOCIATE DIRECTOR: Miguel Forte, MD, PhD: [email protected]

SECRETARY:Anabela Mouro, BSc: [email protected]

PROJECT MANAGER:Joana Tuna, MSc: [email protected]

PROGRAMME WEBSITE:www.pharmaceutical-medicine.pt

ADMINISTRATIVE SUPPORT:Clinical Research OfficeHealth Sciences DepartmentUniversity of Aveiro | 3810-193 Aveiro | PortugalTel. +351 234 370 213 | Fax +351 234 401 597

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OVERVIEWThe “Training Programme in Pharmaceutical Medicine” at the University of Aveiro, in the city of Aveiro, Portugal, has been established since 2010 as an initiative of a group of experts from the academia, regulatory bodies, clinical research sites and pharmaceutical companies that identified a need for continuing education and qualification of pharmaceutical medicine professionals.

The “Training Programme in Pharmaceutical Medicine” is based on curricular units in modular format. Each module has a 3-day face-to-face course plus distance-learning activities. The modular and mixed face-to-face vs. distance-learning structure is designed to fit in with the working lives of full-time professionals allowing to balance work commitments with learning.

The “Training Programme in Pharmaceutical Medicine” has been implemented with the active support and collaboration of the Association of the Portuguese Pharmaceutical Physicians (AMPIF) and the Portuguese Medicines Agency (INFARMED). It offers the following participation modalities:

• Masters in Pharmaceutical Medicine: To meeting the needs of those interested in fulfilling the complete Programme and to obtain a Master Degree in Pharmaceutical Medicine. The programme is composed by a set of nine mandatory curricular units covering the whole contents of PharmaTrain syllabus, plus four optional curricular units and a Thesis.

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• Diploma in Pharmaceutical Medicine: To meeting the needs of those interested in obtaining the Diploma of Post-Graduate Course in Pharmaceutical Medicine. The programme is composed by a set of nine mandatory curricular units covering the whole contents of PharmaTrain syllabus, plus one optional curricular unit.

• Continuing Professional Development (CPD) Courses: Those who do not wish to register for the Masters or Post-Graduate Course have the opportunity to participate in stand-alone training courses. CPD courses are offered in all curricular units, resumed to three days of face-to-face sessions.

The “Training Programme in Pharmaceutical Medicine” was designed to accomplish with the PharmaTrain’s syllabus and standards. It provides generic competences and competences directed to specialization. The generic competences are provided by the nine mandatory curricular units, which altogether cover the PharmaTrain syllabus. Optional curricular units provides the competences directed to a certain specialization, which allows the participants to develop in greater detail certain topics of pharmaceutical medicine according to their personal interests or professional needs.

Since September 2013, the “Training Programme in Pharmaceutical Medicine” has been recognised as a “PharmaTrain Centre of Excellence”. n

1. IMI PharmaTrain Syllabus, V1.0, 10.02.2010: The European Training Syllabus for Pharmaceutical Medicine / Integrated Drug Development Sciences

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MISSION AND AIMS

Mission

The “Training Programme in Pharmaceutical Medicine” has a double mission:• To provide lifelong training in pharmaceutical medicine

of human resources employed by the pharmaceutical and biomedical sectors, research centres, regulatory authorities and other stakeholders involved in the research, development, approval and marketing of drugs, medical devices and other health products.

• To train new human resources that can contribute to boosting biomedical and pharmaceutical R&D in Portugal and abroad.

Aims

The “Training Programme in Pharmaceutical Medicine” gives a broad perspective of product life cycle. Participants will gain competences to work through this cycle particularly on the development and regulatory processes. To achieve this objective, the “Training Programme in Pharmaceutical Medicine” adopted the Learning Outcomes defined for the PharmaTrain programme.

On successful completion of Master in Pharmaceutical Medicine, students should be able to demonstrate an understanding / knowledge of the following:• Outline and critically appraise the principal steps in drug

discovery• Explain the rationale for the complete development plan

(pharmaceutical, pre-clinical and clinical) according to the proposed therapeutic indication

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• Critically review the issues (including legal, ethical and clinical) involved in the undertaking of clinical research

• Appraise and compare the regulation of medicines in the various global markets

• Assess and compare the management of drug safety issues pre- and post-marketing authorisation

• Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions

• Explain the principles of health economics and discuss their application in the development and marketing of medicines

• Critically review and interpret the literature relating to drug research and usage

• Demonstrate competence in the management of all life-cycle activities (regulatory and marketing) of a medicine.

On successful completion of Diploma in Pharmaceutical Medicine students should be able to demonstrate an understanding / knowledge of the following:•The principal steps in drug discovery•The complete development plan (pharmaceutical, non-

clinical and clinical) according to the proposed therapeutic indication

•The pertinent issues involved in the undertaking of clinical research

•The regulation of medicines in the various global markets•The management of drug safety issues pre- and post-

marketing authorisation•Development and review of product-related information

to ensure adherence to ethical and legal provisions•The principles of health economics and their application

in the development and marketing of medicines•The management of all lifecycle activities (regulatory and

marketing) of a medicine. n

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PROGRAMME STRUCTURE

General Format

The “Training Programme in Pharmaceutical Medicine” follows the PharmaTrain Syllabus and is structured in a flexible format in order to address the training needs of different target audiences and to facilitate the participation of active professionals.

The Programme is based on curricular units in modular format. The students receive a comprehensive pre-reading package before each course in order to start the module with basal knowledge about the issues to be addressed. Each course occurs in a 3-day face-to-face session followed by homework and distance-learning activities. The 3-day courses consist on a series of learning events, namely lectures, seminars, presentations and discussion panels. These courses occur in Aveiro, at the facilities of the University of Aveiro, or in Lisbon, at the facilities of the Portuguese Medicines Agency (INFARMED).Distance-learning activities include bibliographic research about specific issues, assignments to be worked on individually and/or in small groups of students and research for preparation to the final examination.

Each curricular unit corresponds to 6 ECTS (European Credit Transfer System), with 1 ECTS corresponding to approximately 27 hours of learning, divided as follows:• Pre-course work and preparation: 1.5 ECTS• Face-to-face 3-days course: 1 ECTS• Post-course work and assignments: 3.5 ECTS.

Master thesis corresponds to 42 ECTS.

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Globally, the competences provided by the “Training Programme in Pharmaceutical Medicine” include generic competences and competences directed to a certain degree of specialization. The global competences are provided by the nine mandatory curricular units, which altogether cover all the aspects of the PharmaTrain Syllabus. The competences directed to a certain degree of specialization are provided by optional curricular units, which allow the participants to develop in greater detail certain topics of pharmaceutical medicine according to their personal interests or professional needs.

Every mandatory curricular unit occurs once a year. The optional curricular units occur when deemed necessary to attend a students’ request.

Participation in the “Training Programme in Pharmaceutical Medicine” requires an adequate command of English. All study materials are presented in English, including the written assignments and examinations. The oral presentation materials (e.g. Powerpoint files) are prepared in English. If foreign participants are registered, all Lecturers are required to do their talks in English. If no foreign participant is registered, Portuguese-speaking Lecturers have the option to present their talks in Portuguese.

The Programme is provided to a maximum of 40 and a minimum of 20 students per year, when the Diploma and Master run simultaneously. The Programme is offered every year and the recommended curriculum for full-time students is up to 60 ECTS per year.

The Programme highlights the involvement of external experts in the teaching staff as a point of additional

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value of the course. The teaching staff is composed by a combination of experts in each of the topics to be addressed. Two Leaders and a variable number of Lecturers teach every course. Above 100 Lecturers are involved in each edition of the Programme, coming from the academia, healthcare providers, pharmaceutical industry, clinical research organisations and competent authorities.

In order to assure total independence from commercial interests, the Programme does not accept any type of financial support from private entities, such as pharmaceutical companies or contract research organisations.

Participants’ fees financially support the course. This income is used to support course logistics, administrative structure and research. The teaching staff may receive traveling cost reimbursement. The course has been self-sustainable in every edition already performed.

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Mandatory Curricular Units

Nine curricular units are mandatory for all registered participants interested into obtaining the Master or the Diploma in Pharmaceutical Medicine. The mandatory curricular units provide the global competences, covering all the topics defined in the PharmaTrain Syllabus for Training in Pharmaceutical Medicine.

Table 1 – Mandatory Curricular Units

Code Title

M01 Introductory Module: Product Research and Development Process

M02 Non-clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery to First in Humans

M03 Exploratory & Confirmatory Clinical Development: Clinical Pharmacology

M04 Clinical Trials: Clinical Development

M05 Regulatory Affairs, Drug Safety & Pharmacovigilance I: Medicines Regulation / Regulatory Affairs

M06 Regulatory Affairs, Drug Safety & Pharmacovigilance II: Drug Safety and Pharmacovigilance

M07 Systematic Review and Meta-analysis: Clinical Data Management and Analysis

M08 Healthcare Marketplace & Economics of Healthcare I: Healthcare Marketplace

M09 Healthcare Marketplace & Economics of Healthcare II: Health Economics

The mandatory curricular units occur once per year.

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Optional Curricular Units

The Programme includes a series of optional curricular units, which can be expanded according to scientific and regulatory developments. New optional curricular units may be created, if considered necessary. Optional curricular units occur when justified.

Table 2 – Optional Curricular Units

Code Title

O01 Project Management in Medicines Development

O03 Medical Writing and Communication

O04 Managing an R&D Project

O05 Informatics in Medicine and Clinical Research

O06 Translational Medicine

O07 Medical Affairs

O08 Statistics Applied to Clinical Research

O09 Quality Management and Inspections

O11 Ethics in Clinical Research: Practical Approach to Ethical & Legal Aspects of Clinical Trials

O12 Principles and Practices of Medical Device Development

The optional curricular units occur when deemed necessary.

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Programme Modalities

The “Training Programme in Pharmaceutical Medicine” offers three modalities of training: • Master in Pharmaceutical Medicine• Diploma in Pharmaceutical Medicine • Continuous Professional Development (CPD) courses. Obtaining a Master Degree in Pharmaceutical Medicine implies:• Approval in nine mandatory curricular units. • Approval in four optional curricular units.• Presentation and successful defence of a final Thesis.

Obtaining a Diploma in Pharmaceutical Medicine implies:• Approval in nine mandatory curricular units.• Approval in one optional curricular unit.

Registered participants in stand-alone CPD courses are awarded with an attendance certificate.

Programme Regimes and Duration

The participant can choose to register in the Programme in full-time or part-time regimen.

Full-time regimen implies enrolling in curricular units up to 60 ECTS (i.e., up to 1o curricular units), per academic year. The minimum time for completion of the Programme is thus 24 months for the Master and 12 months for the Diploma.Part-time regimen implies enrolling in curricular units to a maximum of 30 ECTS (i.e., 5 curricular units) per academic year. n

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TEACHING STAFF Alexandra Pêgo, PharmD Head of the Directorate of Risk Management for Medicines, INFARMED - National Authority of Medicines and Health Products, I.P.

Ana Araújo, PharmD Pharmacist of the Directorate of Risk Management for Medicines, INFARMED - National Authority of Medicines and Health Products, I.P.

Ana Azevedo, MD, PhD Faculty of Medicine, University of Porto

Ana Loureiro, PhD Directorate for the Evaluation of Medicinal Products - Scientific Evaluation Unit, INFARMED - National Authority of Medicines and Health Products, I.P.

Ana Maria Nogueira, MD Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Medical Director, MSD

Ana Ordaz, BSc Oncology Account Manager, Novartis

Ana Paula Martins, PharmD, PhD HMPC/EMA, INFARMED - National Authority of Medicines and Health Products, I.P.

Ana Teresa Pinto, MSc UATEC, University of Aveiro

André Freitas, PharmD Business Development, Bluepharma

André Mota, PharmD Regulatory Affairs Department, Bluepharma

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António Faria Vaz, MD, MSc Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Head of the Ethics Committee,and Head of the Pharmacy and Therapeutics Committee, ARS Lisboa e Vale do Tejo

Antonio Lourenço, MD Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Member of the Executive Committee of the Ethics Committee for Clinical Research, CEIC; Member of Pharmacy and Therapeutic Committee, ARS Lisboa e Vale do Tejo

Augusto Silva, PhD Auxiliary Professor, Department of Electronics, Telecommunications and Informatics, IEETA, University of Aveiro

Barry Drees, PhD Senior Partner, Trilogy Writing and Consulting GmbH

Bruno Gago, PharmD, PhD Deputy Director, Training Programme in Pharmaceutical Medicine; Invited Auxiliary Professor, Health Sciences Department, University of Aveiro

Carlos Costa, PhD Auxiliary Professor, Department of Electronics, Telecommunications and Informatics, IEETA, University of Aveiro

Carlos Faro, PharmD, PhD President, BIOCANT

Carlos Macedo, MD Medical Director, GlaxoSmithKline

Carlos Pinho, PhD Associate Professor, Department of Economics and Industrial Management, University of Aveiro

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Carlos Simões, PharmD, PhD Chief Technology Officer, BSim2 – Biomolecular Simulations, Ltd

Carlyne Averell, PhD Director, Observational Data Analyst – GlaxoSmithKline

Carlos Trabulo, MD Medical Director, Boelhringer Ingelheim

Catarina Pinto, PhD Head of Nonclinical Development, Luzitin SA; Senior Researcher, Bluepharma SA

Celso Guedes de Carvalho, PhD University of Aveiro Business Incubator, IEUA

Céu Mateus, PhD Professor, ENSP, Nova University of Lisbon

Cristina Lopes, PharmD, PhD Clinical Operations Director, Blueclinical Ltd

Cristina Santos, MSc, PharmD Study Coordinator, Portuguese Institute of Oncology – Porto

Dinah Duarte, MSc Head of Scientific Evaluation Unit, Directorate for the Evaluation of Medicinal Products, INFARMED - National Authority of Medicines and Health Products, I.P.

Dirk Teuwen, MD, PhD Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Chief Safety Officer, Vice President Global Clinical Safety and Pharmacovigilance, UCB

Fernanda Ralha, PharmD Director, Licensing, and Inspections Directorate, INFARMED - National Authority of Medicines and Health Products, I.P.

Filipe Rodrigues, PharmD Senior Manager Market Access EMEA, Celgene

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Francisco Pimentel, MD, PhD Medical Director, Lenitudes SA

Francisco Ramos, Economist Professor, National School of Public Health, ENSP, Nova University; President of the Board, Portuguese Institute of Oncology, IPO-Lisbon

Francisco Rocha Gonçalves, PhD Member of the Board, Portuguese Institute of Oncology, Porto

Gabriel Silva, PharmD R&D Department, Bluepharma SA

Gonçalo Nunes, PharmD Regulatory Affairs Manager, Gilead

Graça Freire, PharmD Invited Auxiliary Professor, Health Sciences Department; University of Aveiro; Regulatory Affairs Director, GSK

Graça Silveira, MA Clinical Research Manager, Quintiles

Hélder Mota-Filipe, PharmD, PhD Vice-President of the Board, INFARMED - National Authority of Medicines and Health Products, I.P.; Associate Professor, Faculty of Pharmacy, University of Lisbon

Helena Beaumond, BSc Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Director of the Clinical Trials Unit, INFARMED - National Authority of Medicines and Health Products, I.P.

Helena Ponte, MD Director Serviços de Meios de Defesa Sanitária, DGAV

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Inês Vaz, PharmD, MSc Pharmacist, Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto

Ingrid Klingmann, MD Coordinator, PharmaTrain; Chairman of the Board, European Forum for Good Clinical Practice, EFGCP

Isabel Boaventura, MD Medical Director, Celgene

Isaura Vieira, Economist Director, Economic Evaluation and Market Monitoring, INFARMED - National Authority of Medicines and Health Products, I.P.; Member, WP4 and WP7 - European Network for Health Technology Assessment

James Potter, BSc, MBA Project Management Faculty, University of Virginia, USA

Jean Louis Roux Dit Buissom, BSc, MBA Professor, Grenoble Graduate School of Business; C.E.O., FORO Ventures

Joana Feijó, PhD Critical Health, SA

João Costa, MD, PhD Professor, Laboratory of Pharmacology and Clinical Therapeutics, Faculty of Medicine, University of Lisbon

João Martins, PharmD Director, Medicines Evaluation Directorate DAM, Acting Director of Economic Evaluation, Prices and Reimbursement Department DAEOM, INFARMED - National Authority of Medicines and Health Products, I.P.

João Paulo Guimarães, MD Medical Director, Angelini Farmacêutica

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João Pereira, PhD Professor and Director, National Public Health School, ENSP, Nova University of Lisbon

Joaquim Ferreira, MD, PhD Professor, Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon

Joaquim Marques, PhD Professor, Portuguese Institute of Marketing Administration, Aveiro

Jorge Simões, PhD Invited Full Professor, Health Sciences Department, University of Aveiro; Invited Full Professor, Hygiene and Tropical Medicine Institute, IHMT, Nova University of Lisbon; President of the Portuguese Health Regulation Authority, ERS

José Aleixo Dias, MD, MSc Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Medical Director, Pfizer

José Antunes, MD Medical Director, Janssen-Cilag Farmacêutica

José Luis Oliveira, PhD Associate Professor, Department of Electronics, Telecommunications and Informatics, IEETA, University of Aveiro

José Paulo Raínho, PhD Investigator, UATEC, University of Aveiro

Julia Klaproth-Forjanic, PhD Invites Auxiliary Professor, Health Sciences Department, C.E.O. and Senior Partner, Trilogy Writing and Consulting GmbH

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Judite Neves, PharmD Director, Health Products Directorate, INFARMED - National Authority of Medicines and Health Products, I.P.

Luís Almeida, MD, PhD Director of the Training Programme in Pharmaceutical Medicine; Invited Associate Professor, Health Sciences Department, University of Aveiro; Blueclinical Ltd; Luzitin SA; ARC Publishing

Luís Arnaut, PhD Full Professor, Faculty of Sciences, University of Coimbra; Chief Scientific Officer, Luzitin SA

Luís Cardia, MBA Professor, Oporto Business School

Luís Veloso, BSc Medical Writing Unit Head, Eurotrials SA

Margarida Carvalho, PharmD Regulatory Affairs, GlaxoSmithKline

Margarida Menezes Ferreira, PhD Scientific and Regulatory Advice Coordinator; Senior Assessor - Medicines Evaluation Department; INFARMED - National Authority of Medicines and Health Products, I.P.; Member of the Committee for Advanced Therapies CAT and of the Biologics and Working Party / CHMP – EMA

Margarida Mesquita, PharmD Quality Assurance Department, Bluepharma SA

Maria Emília Rodrigues, PharmD Head of Regulatory Affairs, Sanofi-Aventis

Mário Miguel Rosa, MD, PhD Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon

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Marta Marcelino, PharmD Director, Directorate for Evaluation of Medicines, DAM/UIM, INFARMED - National Authority of Medicines and Health Products, I.P.

Marta Pereira, MSc Faculty of Medicine, University of Porto

Miguel Forte, MD, PhD Invited Associate Professor, University of Aveiro; Cfief Medical Officer, TxCell

Mónica Galo, PharmD Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Quality Assurance Development Manager, Novartis

Nelson Rocha, PhD Full Professor, Health Sciences Department, University of Aveiro; Director, Clinical Research Office, Health Sciences Department, University of Aveiro

Nuno Cobrado, PharmD, MSc Hospital Strategy Strategic Manager, Novartis

Nuno Monteiro, PhD Critical Health, SA

Paula Dias de Almeida, PharmD Member of Executive Board of INFARMED - National Authority of Medicines and Health Products, I.P.

Paulo Fontoura, MD, PhD Invited Associate Professor, Health Sciences Department, University of Aveiro; Head of Translational Medicine CNS, F. Hoffman-La Roche, Basel

Pedro Crisanto, PharmD Clinical Research Manager, Servier

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Pedro Sá Couto, PhD Auxiliary Professor, Mathematics Department, University of Aveiro

Peter Schueler, MD Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Senior Vice President Medical & Safety Services, ICON plc

Raquel Lucas, PhD Faculty of Medicine, University of Porto

Raquel Reis, BSc Head of Clinical Trials, Eurotrials SA

Ricardo Fernandes, MD Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon

Rita Duarte, PharmD Clinical Trial Assistant & Quality Check Responsible, Bayer

Roberto Pinto, MD Faculty of Medicine, University of Porto

Rita Espanha, PhD Investigator – Center of Research and Studies in Sociology – University Institute of Lisbon

Rui Sousa, MSc, MD International Medical Manager, Bial SA

Samuel Silvestre, PharmD, PhD Professor, University of Beira Interior, UBI

Sandra Lang, MSc Project Management Director, PharmaNet/i3

Sandra Madaleno, PharmD, MSc Country Safety Lead, Pfizer

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Serafim Guimarães, MD Nefrologist, Centro Hospitalar Gaia-Espinho; Medical Director, Blueclinical Phase I

Sérgio Simões, PharmD, PhD Associate Professor, Faculty of Pharmacy, University of Coimbra; Bluepharma SA, Treat U SA, Luzitin SA and Blueclinical Ltd;

Sónia Alfar, PharmD, MSc Galenical and Analytical Development Manager, Bluepharma SA

Sonia Castanheira, ChemEng R&D Department, Bluepharma SA

Susana Gonçalves, PharmD Clinical Trial Manager, Amgen

Tânia Silva, MSc Business Solution Specialist, IMS Health

Teresa Herdeiro, PharmD, PhD Invited Professor, Health Sciences Department, University of Aveiro

Teresa Nunes, MD, MSc, MBA Independent Consultant

Vasco da Gama, MD Director, Cardiology Department, Centro Hospitalar V. N. Gaia / Espinho, EPE

Vera Afreixo, PhD Auxiliary Professor, Department of Mathematics, University of Aveiro

Vítor Neves, Eng President, EUROPACOLON.

Note: Other experts will join the 2013-2014 Teaching Staff. n

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Code Title

M01Introductory Module: Product Research and Development Process

M02Non-clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery to First in Humans


M04Clinical Trials: Clinical Development

M05Regulatory Affairs, Drug Safety & Pharmacovigilance I: Medicines Regulation / Regulatory Affairs

M06Regulatory Affairs, Drug Safety & Pharmacovigilance II: Drug Safety and Pharmacovigilance

M07Systematic Review and Meta-analysis: Clinical Data Management and Analysis

M08Healthcare Marketplace & Economics of Healthcare I: Healthcare Marketplace

M09Healthcare Marketplace & Economics of Healthcare II: Health Economics

MA

NDA

TORY

CU

RR

ICU

LAR

UN

ITS

DETAILS OF EACH CURRICULAR UNIT MANDATORY CURRICULAR UNITS

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M01Introductory Module:Product Research and Development Process

PharmaTrain ReferencePharmatrain Base Course Module M01a (INT): Introductory module & Module BCM1b: Principles of discovery of medicines and development planning, May 2012, v2.0

This module is a mandatory part of the curricular unit “Product Research and Development Process”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Helena Beaumont, BSc (Director of the Clinical Trials

Unit, INFARMED - National Authority of Medicines and Health Products, IP; Invited Auxilliary Professor, Health Sciences Department, University of Aveiro)

• Luis Almeida, MD, PhD (Director of the Training Programme in Pharmaceutical Medicine; Invited Associate Professor, Health Sciences Department, University of Aveiro; Managing Partner, Blueclinical Ltd.; Managing Partner, ARC Publishing; C.E.O, Luzitin S.A.)

M01

Main Bibliography• “Principles and Practice of Pharmaceutical Medicine”, 3rd

ed. Edited by Edwards LD, Fox AW & Stonier PD. Wiley-Blackwell, 2011.

• “The Textbook of Pharmaceutical Medicine”, 6th ed. Edited by Griffin JP. Wiley-Blackwell, 2009.

Accreditation • The University of Aveiro credits this curricular unit with

6 ECTS. • Attendance of the 3-day course is credited with 1.9 CDP by

the Portuguese Pharmaceutical Association (Ordem dos Farmacêuticos).

LEARNING OUTCOMES

On successful completion of this Module the student should be able to:

1. Outline the process of drug development and identity of critical factors and decision points.

2. Explain the importance of the patient in drug development.

3. Describe the background to the development of the regulation of medicines and the role of the competent authorities.

4. Outline the monitoring of drug safety.

5. Describe the principles & practice of medical marketing.

6. Outline the role of pathophysiology and molecular biology-based pharmacology in drug development.

7. Describe the principal steps in discovering, modifying, assessing and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication.

M01

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8. Discuss the resource planning (in terms of project management, budgeting and cost- control) involved in the management of a drug development programme.

9. Describe the principles of translational research and its role in drug development.

10. Outline the functions and elements (including business aspects) involved in the integrated development of a new drug.

M01 CURRICULUM CONTENT LEARNING OUTCOMES MAPPING

SYLLABUS MAPPING

1.1 Setting the scene: Medicines market overview and the Industry we are in.

1, 2, 3, 5 13.6, 13.8

1.2 Meeting the challenges of developing new, more effective, safer medicines.

1, 2, 3

1.3 The highly regulated and ethical environment of medicines development.

1, 3 2.2, 8.1

1.4 The patient’s view. 2

1.5 The discovery process and non-clinical development.

1

1.6 The target product profile (TPP) as the blueprint; satisfying the patients, doctors, regulators and payers.

1, 2, 3, 5

1.7 A helicopter view of Integrated drug development including: attrition, orientation of the phases (0, 1, 2a, 2b, 3 & 4); modern approaches (learn, confirm) and conditional approvals.

1

1.8 Exploratory Development: translational medicine; predictive science and personalised health care.

1, 2

1.9 Confirmatory Development. 1, 2

1.10 Principles of drug regulation and approval. 3

M01

1.11 Patient safety, pharmacovigilance and pharmacoepidemiology.

4

1.12 The payers, market support activities and health economics.

5

1.13 Strategy and organisation of research including collaborative approaches e.g. with academia.

10 1.1

1.14 Disease models; target identification, validation and selection. Principle steps in discovering, modifying, assessing and patenting new chemical and biological compounds.

7 1.2, 1.4

1.15 Pathophysiology and molecular biology-based pharmacology. Molecular-based approaches: agonists, antagonists, enzyme inhibitors; genomics, proteomics, epigenetics.

6 1.3, 3.1

1.16 Chemical and biological medicinal agents, natural medicines, medicine-coupled devices and advanced therapies.

6, 7 1.5

1.17 Lead optimisation and development candidate selection; testing for biological activity.

7 1.6, 1.7

1.18 Principles of translational medicine: relationship between animal and human pharmacology, molecular biological and physiological approach e.g. biomarkers, functional imaging, modelling &simulation.

9 1.8, 1.9

1.19 Global integrated development of new medicines, including quality management.

10 2.1, 2.2, 2.5

1.20 Project management techniques: central role of development plan, project teams, tools and decision- making from target product profile (TPP) and target product claims (TPC) to registration dossier submission. Resource planning, budgeting and cost control, in- sourcing and out-sourcing.

2.3, 2.7

M01

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1.21 Development programme planning for small and / or special populations.

7 2.4

1.22 R&D portfolio planning; in-licensing and out-licensing of medicines.

10 2.6

1.23 Therapeutic Topic 1 14.1–14.10

1.24 Therapeutic Topic 2 14.1–14.10

M01

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M02Non-Clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery To First In Humans

PharmaTrain ReferencePharmatrain Base Course Module BCM 2: Non-Clinical Testing, Pharmaceutical And Early Clinical Development, May 2012, v2.0

This module is a mandatory part of the curricular unit “Non-Clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery To First In Humans”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders• Bruno Gago, PharmD, PhD (Deputy Director, Training

Programme in Pharmaceutical Medicine; Invited Auxilliary Professor, Health Sciences Department, University of Aveiro)

• Sérgio Simões, PharmD, MSc, PhD (Associate Professor, Faculty of Pharmacy, University of Coimbra; Vice-President of Bluepharma S.A.; Chairman, Luzitin S.A.; Chairman, Treat U S.A.; Managing Partner, Blueclinical Ltd.)

M02

Main Bibliography• “Principles and Practice of Pharmaceutical Medicine”, 3rd



• “Nonclinical Drug Safety Assessment – Practical Considerations for Successful Registration”. Edited by Sietsema WK and Schwen R. FDAnews, 2007.


6 ECTS. • Attendance of the 3-day course is credited with 1.75 CDP

by the Portuguese Pharmaceutical Association (Ordem dos Farmacêuticos).

LEARNING OUTCOMES


1. Discuss the choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds.

2. Describe the integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials).

3. Outline the steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds).

4. Describe the planning of clinical trial supplies for test substance(s) and comparators (active and placebo).

M02

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5. Provide an overview of non-clinical study requirements prior to First-in-Man studies.

6. Discuss the molecular and cellular basis of toxic reactions.

7. Outline the principles and practical application of pharmacokinetics & toxicokinetics.

8. Outline the early exploratory development in man.

9. Discuss the principles of clinical pharmacology and their application to clinical development.

10. Describe the influence of genetic factors in drug development and drug response.


SYLLABUS MAPPING

2.1 Principles of non-clinical testing: differences & similarities between small molecule and biological macromolecule active agents and between the pharmacology & toxicology of compounds and their metabolites in animals & man, and their qualitative & quantitative assessment.

1 3. 2, 3.3

2.2 Descriptive & quantitative in vitro & in vivo testing of new compounds; the choice and predictive value of these tests for acute, chronic, reproductive, genetic & immune toxicology, and carcinogenicity.

1 1.7, 3.4,3.5

2.3 Common mechanisms of damage to organs: their detection and elucidation. Molecular and cellular basis of toxic reactions.

6 3.6

M02

2.4 The scheduling of toxicology tests linked to development plans, regulatory needs, human & animal pharmacology, and to intended clinical uses & route(s) of administration. The size, cost and administration of the toxicology programme, its data management, quality assurance and report writing.

2 3.7, 3.8

2.5 The continuous review of toxicology, its inclusion into clinical trial protocols and investigator brochures, and the planning and correlation with the clinical evaluation of potential and observed toxicity in patients.

2 3.9

2.6 Safety pharmacology; hypersensitivity. 5, 6 3.10

2.7 In vitro & in vivo study of metabolism; Absorption, Distribution, Metabolism, Elimination (ADME); Toxicokinetics.

7 3.11

2.8 Pharmaceutical development of drug substance (small chemical molecules or biological macromolecules) and up-scaling: manufacture & supply of materials; stability and storage; purity; compatibility; disposal.

3 4.1

2.9 Pharmaceutical development of drug product and up- scaling: formulation(s); manufacture and supply of materials; labelling & presentation; stability & storage; purity; compatibility; disposal.

3 4.1, 4.2

2.10 Choice of formulations and delivery systems depending on characteristics of compound and intended uses; testing formulations leading to a final specification, including bioequivalence.

3 4.3, 4.4

2.11 Safety specification; pharmacopoeias. 3 10.20, 10.22

M02

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2.12 The concept of blinding: preparing matching placebo and comparator products. Planning clinical trials supply requirements; packaging and labelling of clinical trial supplies (including stability and storage requirements); distributing supplies and disposing of remaining stocks.

4 4.5, 4.6,7.14

2.13 Assessment of non-clinical data and risk as prerequisites before administration to man: description of intended therapeutic indications, biomarkers, surrogate endpoints and criteria for ‘go’ ‘no-go’ decisions.

5, 7 5.1, 5.2

2.14 The early clinical development plan: objectives, design, conduct and analysis; tolerability, metabolism, pharmacokinetics, pharmacodynamics and safety in man; risk mitigation strategies; first-into-man studies, including exploratory strategies (Phase 0).

8 5.3, 5.4

2.15 Clinical pharmacodynamics & pharmacokinetics: ADME; determinants of PK parameters; bioavailability & bioequivalence; extrinsic & intrinsic factors affecting drug metabolism (e.g. drug-drug, drug-food, drug-disease interactions).

9 5.5, 5.6, 5.7, 5.8

2.16 Pharmacogenetics, pharmacogenomics, population pharmacokinetics, genetic factors influencing PK, PD and response to therapy. Personalised medicine.

3, 10 5.9, 5.10

2.17 Applicability of pharmacokinetics to dosage regimen and study design. Pharmacokinetic / pharmacodynamic modelling and simulation.

9 5.11

2.18 Therapeutic Topic 3 14.1 – 14.10

2.19 Therapeutic Topic 4 14.1 – 14.10

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PharmaTrain ReferencePharmatrain Base Course Module BCM3: Exploratory & confirmatory clinical development, May 2012, v2.0

This module is a mandatory part of the curricular unit “Exploratory & Confirmatory Clinical Development: Clinical Pharmacology”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Luis Almeida, MD, PhD (Director of the Training Programme

in Pharmaceutical Medicine; Invited Associate Professor, Health Sciences Department, University of Aveiro; Managing Partner, Blueclinical Ltd.; Managing Partner, ARC Publishing; C.E.O, Luzitin S.A.)

• Teresa Nunes, MD, MSc, MBA (Independent Consultant)

Main Bibliography • “Principles and Practice of Pharmaceutical Medicine”, 3rd ed.

Edited by Edwards LD, Fox AW & Stonier PD. Wiley-Blackwell, 2011.


• “Drug and Biological Development - From Molecule to Product Development and Beyond”. Edited by Evens R. Springer, 2007.

M03

• “Principles and Practice of Clinical Research”, 3rd ed. Edited by Gallin JI & Ognibene FP. Academic Press, 2010.

Accreditation • The University of Aveiro credits this curricular unit with 6

ECTS. • Attendance of the 3-day course is credited with 2.2 CDP by


LEARNING OUTCOMES


1. Describe the early studies in patients: dose-finding / proof of concept studies and their impact on drug development plan.

2. Outline the design of clinical trials, including legal, regulatory, ethical & practical aspects and Good Clinical Practice (GCP).

3. Discuss the principles and application of statistics in clinical trials.

4. Describe the procedures for clinical trial data collection (paper & electronic) and data management (including validation processes) to ensure optimal quality data.

5. Identify the key strategic and operational issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP).

6. Describe the role of the Investigator Drug Brochure (IDB).

7. Discuss the principles and practical relevance of ethical issues in biomedical research.

8. Outline the legal and ethical provisions for protection of clinical trial subjects.

M03

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SYLLABUS MAPPING

3.1 First administration to patients; principles of proof of concept and dose-finding studies.

1 5.12

3.2 Concept of blinding. 2 4.5

3.3 Trial design: pre-trial decisions and specifications; literature review; incidence & prevalence of the disease; risk factors; confounding variables; dealing with confounding factors and bias; review of literature.

2 9.8, 9.25, 9.11, 9.20, 9.24

3.4 Clinical trials regulations; EU Directives & Guidances and their diversity in national implementation; CTA including IMPD, substantial amendments. Clinical trial regulations in other regions e.g. the US IND process.

2, 5 10.10

3.5 Protocol writing: detailing choice of location(s), trial design, blinding, placebo or other comparators, endpoints, patient population, informed consent, sample size, randomisation, statistical methods, interim analysis.

2, 3 7.6

3.6 Analysis of efficacy endpoints and of safety (intention to treat principles, handling of missing data etc.); interim analysis; statistical tests (sensitivity & specificity of tests; paired & non-paired tests, parametric & non-parametric tests, confidence limits).

3 9.14, 9.15, 9.16, 9.18, 9.19

3.7 Options for data collection (manual & electronic) and standardisation; creation, maintenance and security of databases, software validation and archiving.

4 9.1, 9.3

3.8 Case report form (CRF) design and review. 4 9.2

M03

3.9 The purpose and fundamentals of statistics. The role & responsibilities of the statistician. Statistical considerations of study design: hypothesis testing (the Null hypothesis, type I & type II error, significance, power), randomisation, sample size. The Statistical Analysis Plan (SAP), including interim analysis.

3 9.5, 9.6, 9.7, 9.9, 9.10, 9.11,

3.10 Principles of Good Clinical Practice (GCP) and procedures applied in all stages of the clinical trial process to ensure subject protection, scientific validity and safety. Clinical trial registries.

5 9.15

3.11 Investigator Brochure: content, review and maintenance.

6 7.4, 7.11

3.12 Ethics: principles, history including Declaration of Helsinki, EU Directive 2001/20/EC, ethical review process, informed consent, safety & human dignity of research subjects. Ethical issues in biomedical research and pharmaceutical medicine.

7 7.5

3.13 Protection of research subjects. Risks, benefits and burden of study participation. Minimising risk including site qualification assessment; ethical aspects of subject contact and recruitment, and of reimbursement, compensation and inducement; indemnity and insurance for participants, investigators, institutions; complaint procedures.

7, 8 8.1, 8.2

3.14 Ethical aspects of research questions and study designs for first-in-human to post-marketing and epidemiological studies, including post-study follow-up procedures, placebo and comparator choice.

7, 8 8.3, 8.6, 8.7, 8.8, 8.11

M03

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3.15 Conflict of interest and equipoise. 8 8.4, 8.12

3.16 The informed consent process. Privacy, confidentiality and data protection.

7, 8 8.5

3.17 Ethical aspects of taking trial samples for genomic and related analyses.

8 8.9, 8.10

3.18 Ethical aspects of clinical trials in vulnerable populations.

8 8.13

3.19 Ethical aspects of advanced therapy medicinal products.

8 8.14

3.20 Ethical aspects of international clinical trials, considering socio-cultural differences.

7, 8 8.15

3.21 Therapeutic Topic 5 8.16

3.22 Therapeutic Topic 6 14.1 -14.10

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M04Clinical Trials: Clinical Development

PharmaTrain ReferencePharmatrain Base Course Module BCM 4: Clinical Trials, May 2012, v2.0

This module is a mandatory part of the curricular unit “Clinical Development”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Miguel Forte, MD, PhD, FFPM (Invited Associate

Professor, Health Sciences Department, University of Aveiro; Chief Medical Officer, TxCell)

• Peter Schuler, MD (Invited Professor, Health Sciences Department, University of Aveiro; Senior Vice-President, ICON plc)

Main Bibliography • “Principles and Practice of Pharmaceutical Medicine”, 3rd



• “Principles and Practice of Clinical Research”, 3rd ed. Edited by Gallin JI & Ognibene FP. Academic Press, 2010.

M04




LEARNING OUTCOMES


1. Describe the various types of clinical studies and the methods used to choose the appropriate design.

2. Describe the main statistical methods used in clinical research.

3. Identify the key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution.

4. Discuss the collection, evaluation and reporting of adverse event data in clinical trials.

5. Outline the various quality management issues in clinical trials.

6. Describe the impact of emerging results on the drug development plan.

7. Outline the key operational and strategic issues in the clinical development plan.

8. Explain the evaluation of the outcome of drug development: final therapeutic profile/usage of a medicine.

9. Describe the role of the Target Product Profile (TPP) and Target Product Claims (TPC).

10. Explain the role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees.

11. Discuss the statistical issues in statistical report writing.

M04

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12. Describe the evaluation and interpretation of clinical trial results.

13. Illustrate the principles and practical application of critical appraisal.


SYLLABUS MAPPING

4.1 Choice of interventional clinical trial design, of placebo and other comparators, of patient populations, of locations. New trial designs e.g. adaptive design.Non-interventional / observational study design.

1 7.1, 7.2,7.3

4.2 Types of data and standardization of measurement e.g. handling of rating scales, including visual analogue scales and laboratory values. Statistical analysis of efficacy end-points and of safety. Patient-reported outcomes e.g. diaries; quality-of-life measures.

2 9.12, 9.13

4.3 Feasibility testing and investigator recruitment; pre-study visits and investigator meetings; investigator training; contractual arrangements with investigators and contract research organizations, including matters such as publication rights and conflicts of interest.

3 7.7, 7.8,7.10

4.4 Project management: EUDRACT, CTA and ethics opinion, resources and budget, timelines, conflict resolution (e.g. investigator discontinuation).

3 7.9

M04

4.5 Clinical trial conduct / Investigative site management: Trial Master File (TMF), monitoring and source document verification, study medication handling and drug accountability.Within-trial decisions (e.g. code-breaking, premature termination); emergency coverage.

3 7.12, 7.13,7.14, 7.15,7.16, 7.17

4.6 Quality management: quality assurance and quality control; SOPs; audits; inspections.

5 7.18

4.7 Fraud & misconduct in biomedical research and clinical development.

3, 5 8.17

4.8 Assessment and classification of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs); evidence for association and causality.

3, 4 11.2

4.9 Collection of adverse events in clinical trials; role of sponsors and investigators in reporting; regulatory requirements.

3, 4 11.4, 11.5

4.10 Impact of results on the drug development plan (DDP) and possible need for further toxicology / pharmaceutical development data; regulatory review of existing and emerging research results.

6 5.13, 6.6

4.11 Final definition of therapeutic indications.Categories of patients, delivery system(s),

dosage forms and dosage regimens.

8 6.1

4.12 Planning & global coordination / harmonisation of pre- and post-licensing clinical trial programmes; use of non- clinical and existing clinical trial data.

7 6.2

M04

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4.13 Decision points, schedules and resources required for confirmatory clinical development plan (CDP). Calculation of clinical trial supplies and costs up to registration.

7 6.3, 6.4

4.14 Review & maintenance of Target Product Profile (TPP) and Target Product Claims (TPC).

9 2.3

4.15 The role of the independent Drug Safety MonitoringBoard (DSMB) and other relevant study committees.

10 7.13

4.16 Measurement and types of data; monitoring of clinical trials; source document verification, CRF review and correction, data entry, query generation and resolution, coding of adverse events, database lock.

2, 4 7.16, 9.4

4.17 Preparing the statistical report: interpretation of analyses; assessment of violations, withdrawals, errors, bias; data manipulation, transformation and merging.

11 9.21, 9.22

4.18 Clinical interpretation of study analyses and results.The Clinical Trial Report.

12 7.19, 9.23

4.19 Critical review of publications. 13 9.25

4.20 Therapeutic Topic 7 14.1-14.10


M04

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M05Regulatory Affairs, Drug Safety & Pharmacovigilance I:Medicines Regulation / Regulatory Affairs

PharmaTrain ReferencePharmatrain Base Course Module ELM 1: Medicines Regulation, January 2012, v1.0

This module is a mandatory part of the curricular unit “Regulatory Affairs, Drug Safety & Pharmacovigilance I: Medicines Regulation/ Regulatory Affairs”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Graça Freire, PharmD (Invited Auxilliary Professor,

Health Sciences Department, University of Aveiro; Head of Regulatory Affairs & Compliance, GlaxoSmithKline)

• Hélder Mota-Filipe, PharmD, PhD (Vice-President of the Board, INFARMED - National Authority of Medicines and Health Products, IP; Associate Professor, Faculty of Pharmacy, University of Lisbon)



M05


• “Eudralex volume 1-10”, European Commission.




LEARNING OUTCOMES


1. Describe the background to the development of medicines regulation at a global level & discuss the similarities & differences between the current regulatory systems in the major regions (EU, US, Japan, ROW).

2. Describe the role & importance of the practical input from expert international bodies including WHO, CIOMS, WMA, in the oversight of medicines regulation.

3. Critically review & evaluate the similarities & differences in legislation relating to drug development in the different regions & explain the impact on the various stakeholders, including regulators, pharmaceutical companies, healthcare professionals & patients.

4. Compare & contrast the legal requirements regarding the provision of product information between the major regulatory regions.

5. Synthesise the post-marketing activities undertaken by the marketing authorisation holder & the regulatory agencies, & their associated interaction, as part of the life-cycle management of an authorised medicine.

M05

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6. Explain the background to the development of the International Conference on Harmonisation.

7. (ICH) & evaluate its role & main activities, including the Common Technical Document (CTD).

8. Describe & appraise the medicines legislation underpinning therapeutic areas, including paediatric use, orphan drugs, advanced therapies & biosimilars in the EU & other major regions.

9. Explain the principles & practical application of the Medical Devices regulations in the EU & other major regions.


SYLLABUS MAPPING

5.1 Background to & general principles of medicines regulation at a global level: differences & similarities between the major regions (EU, US, Japan, ROW).

1, 3 10.1,10.9

5.2 Philosophy of regulatory oversight; practical input from international bodies e.g. WHO, WMA, CIOMS.

2 10.2

5.3 The International Conference on Harmonisation (ICH):• Background to development of ICH;• Main activities;• Common Technical Document;• Future activities.

7 10.4, 10.5, 10.11, 10.12

5.4 Current EU Regulatory requirements for drug development:• EU Directives vs. Regulations;• Regulation of novel vs. established active

ingredients;• Clinical trial legislation;• Centralised vs. Decentralised

applications;• Procedures for approval, rejection, appeal;

3, 8 10.3, 10.5, 10.6, 10.7, 10.8, 10.9, 10.10, 10.13, 10.16, 10.17

M05

• Special therapeutic groups: orphan drugs, paediatrics, advanced therapies, generics, biosimilars;

• Prescription-Only & Over-The-Counter medicines;

• Provisions for & use of unlicensed medicines;

• Role of the European Medicines Agency (EMA) & National Agencies;

• Impact on the activities of the pharmaceutical Industry.

5.5 Regulatory management systems in US, Japan, ROW & local special requirements:• Current non-EU regulatory requirements

for drug development;• Differences & similarities with EU

regulatory system;• Regulation of novel vs. established active

ingredients;• Clinical trials legislation;• Preparation of marketing applications in

non-EU countries;• Special therapeutics groups in non-

EU areas: orphan drugs, paediatrics, advanced therapies, generics, biosimilars;

• Impact on the activities of the pharmaceutical Industry;

• Herbal & traditional medicines, including, for example, TCM (Traditional Chinese Medicines) & ITHM (Indian Traditional Herbal Medicines).

3, 8 10.3, 10.5, 10.8, 10.9, 10.10, 10.13

5.6 Post-authorisation regulation:• Maintenance of the marketing

authorisation• Risk management: Risk Management

Plans (RMPs) in the EU; Risk Evaluation & Mitigation Strategies (REMS) in the USA;

• Safety Specification;• Referral procedures;• Product defects & withdrawals.

5, 6 10.6, 10.18, 10.21, 10.22, 10.23, 10.24

M05

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5.7 Product information regulation:• Summary of Product Characteristics;• Package Insert;• Patient Information Leaflets;• Labelling;• Advertising & promotion regulation.

4, 5 10.9, 10.14, 10.15, 10.23

5.8 Medical device regulations in the EU & non-EU.

9 10.19

5.9 Drug regulation versus Health Technology Assessment: similarities & differences.

3, 5 10.1, 10.3, 13.11

M05

M05

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M06Regulatory Affairs, Drug Safety & Pharmacovigilance II: Drug Safety- Pharmacoepidemiology, Pharmacovigilance And Risk Management

PharmaTrain ReferencePharmatrain Course Module EXM 2: Drug Safety: Pharmacoepidemiology, Pharmacovigilance And Risk Management, May 2012, v2.0

This module is a mandatory part of the curricular unit “Regulatory Affairs, Drug Safety & Pharmacovigilance II: Drug Safety- Pharmacoepidemiology, Pharmacovigilance And Risk Management”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Teresa Herdeiro, PharmD, MSc, PhD (Invited Auxilliary Professor,

Health Sciences Department, University of Aveiro; Scientific Consultant, Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto)

• Dirk Teuwen, MD, PhD (Invited Auxilliary Professor, Health Sciences Department, University of Aveiro; Chief Safety Officer, Vice President Global Clinical Safety and Pharmacovigilance, UCB)

M06

Main Bibliography • The European Parliament and the Council of the

European Union. Directive 2010/84/EU on the Community code on medicinal products for Human use, 15th December 2010 (which amends Directive 2001/83/EC in what regards Pharmacovigilance).

• The European Parliament and the Council of the European Union. Regulation (EU) No. 1235/2010, 15th December 2010 (which amends Regulation No. 726/2004).

• Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012.

• Portuguese Ministry of Health. Dec. Law 20/2013, 14th February (which amends Dec. Law 176/2006, 30th August).

• European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) - Modules I, III- VII, June 2012 and Modules II, VIII, X and XV, April 2013.”




LEARNING OUTCOMES


1. Explain the role of Pharmacovigilance in monitoring of drugs in non-clinical & clinical research and in the marketplace.

M06

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2. Appraise common nomenclature associated with pharmacovigilance (including AE & ADR, Listedness, Expectedness, etc).

3. Demonstrate the sources of safety data: methods for collection, analysis, interpretation and reporting drug safety data, including electronic safety data reporting.

4. Evaluate the assessment of causality.

5. Analyse the application of signal generation and handling of drug safety data in pre-marketing (clinical trial) and post-marketing (pharmacovigilance) contexts, including automated methods.

6. Explain the principles of pharmacoepidemiology and examine the different types of pharmaco-epidemiological studies used in evaluating drug safety including the choice of the most appropriate study design.

7. Describe pharmacovigilance aspects of medicines regulation throughout the life-cycle of a medicine.

8. Critically appraise the principles of risk-benefit analysis and management using qualitative and quantitative approaches.

9. Evaluate the background and purposes of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).

10.Describe the role of the EU Qualified Person in PharmacoVigilance (QPPV).

11. Describe major routes for reporting and communication of pharmacovigilance data.

12.Evaluate the aetiology, mechanisms and pathology of major classes of adverse drug reactions and interactions.

M06


SYLLABUS MAPPING

6.1 Background to and general principles of medicines regulation (with reference to PV responsibilities of all takeholders).Regulatory requirements and legal aspects of Pharmacovigilance.Good Pharmacovigilance Practice (GPvP).The evolution of drug surveillance methods and pharmacovigilance regulations worldwide, their harmonisation, and company systems for assembling and reporting adverse events.

1, 7, 10 10.1, 10.5

6.2 Practical input of international bodies e.g. WHO, WMA, CIOMS, CHMP, ICH and national agencies in the regulatory oversight of pharmacovigilance.

1 10.2, 10.4

6.3 The role of the pharmaceutical professional in drug safety and pharmacovigilance:• the responsibilities and liabilities of

investigators, clinicians, study monitors and manufacturers in the pre- & post-marketing phases to detect, assess and report adverse events associated with medicines;

• the roles & responsibilities of the EEA Qualified Person for Pharmacovigilance (QPPV).

10 11.1

6.4 Assessment and classification of adverse events (AEs), adverse drug reactions (ADRs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).The principles of causality assessment:• evidence for association and causality;• causality algorithms to classify events as to

their likely causal attribution to a particular medicine.

Case narrative writing for reporting adverse events.

2, 3, 4 11.2

M06

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6.5 The concept of benefit/risk assessment, determination of causal relationship between the medicinal product and the adverse event.

4, 8 11.3

6.6 Pre-clinical safety and mechanisms of ADRs. The mechanisms of drug interactions.

1, 8, 12 14.6

6.7 Collection of adverse events in clinical trials:• adverse event assessment and reporting in

clinical trials;• the structure, roles & responsibilities of the

data safety monitoring board (DSMB) in clinical trials.

1, 5, 7 7.15, 11.4

6.8 Role of sponsors and investigators in reporting adverse events & suspected adverse drug reactions.The characteristics that make an AE/ADR reportable according to international guidelines.

1, 5, 7 11.5

6.9 Drug safety in the marketplace:• spontaneous reporting post-marketing;• Prescription Event Monitoring (PEM).

1, 3, 5, 10 11.7

6.10 Periodic Safety Update Reports. 3, 7 11.10

6.11 Risk factors for adverse events. 1, 4, 5, 12 11.6

6.12 Dosage, accumulation, medication errors and interactions.

1, 3, 5 11.8

6.13 Drug adherence / compliance. 1 11.9

6.14 Advanced Pharmacoepidemiology:• main sources of epidemiological

pharmacovigilance information;• non-interventional / observational study

design in pharmacoepidemiology;• dealing with confounding factors and bias.

6 11.11, 11.12, 7.39.24

M06

6.15 Record Linkage and pharmacovigilance databases:• the characteristics of commonly used

databases;• General Practice Research Database (GPRD)

and others. The major methods of post-marketing surveillance.The requirements for Post-Authorisation Safety Studies PASS).

3, 5, 7 11.11

6.16 The methods and applications of all signal generation methods in pharmacovigilance and the processes required for prioritisation and evaluation of detected signals.Benefit-Risk review.The European procedures for reassessment of benefit-risk.

5, 8 11.13

6.17 Regulatory actions in drug safety including:• Marketing Authorisation (MA) Variations,

Urgent Safety• Restrictions, MA suspension and withdrawal;• Risk minimisation strategies.

1, 7, 11 11.15

6.18 Post-authorisation risk management including issue and crisis management.

9, 11 11.15

6.19 Risk management:• Risk Management Plans (RMPs) in the EU;• Risk Evaluation and Mitigation Strategies

(REMS) in the USA.

9 10.21

6.20 Risk communication:• the requirements for informing prescribers,

investigators, ethics committees, and regulatory agencies of important safety concerns;

• Direct Healthcare Professional Communication (DHPC) related to drug safety issues;

• the external factors affecting response to drug safety issues (e.g. public freedom, political agendas, patient organisations).

7, 11 11.16, 10.23

M06

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6.21 Product defects and recall. Communications to doctors and patients.

7, 11 10.18

6.22 Principles & process for development of Safety Specifications documents.

1, 7 10.22

6.23 Impact of emerging safety issues on Product Information.

11 12.2

6.24 Defining the key markers of progress – examination of evidence that the output from safety surveillance systems has improved and safeguarded (public) health.The CYP450 isoenzymes and their role in safety aspects of medicines development and surveillance.Safety aspects of gene therapy and other new technologies. The potential for pharmacogenomics / pharmacogenetics to enhance the safety of medicines.

1 11.1

M06

M06

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M07Systematic review and meta-analysis: Clinical Data Management and Analysis

PharmaTrain ReferencePharmatrain Course Module ELM9: Systematic review and meta-analysis, January 2012, v1.0

This module is a mandatory part of the curricular unit “Systematic review and meta-analysis: Clinical Data Management and Analysis”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Joaquim Ferreira, MD, PhD (Professor, Laboratory of

Pharmacology and Clinical Therapeutics, Faculty of Medicine, University of Lisbon)

• Vera Afreixo, PhD (Professor, Mathematics Department, University of Aveiro; Clinical Research Office, Health Sciences Department, University of Aveiro)

Main Bibliography • “Introduction to Metanalysis”, Borenstein M. et al. Jonh

Wiley & Sons, Inc, 2009.

M07




LEARNING OUTCOMES


1. Appraise different methodologies for carrying out systematic review & meta-analysis.

2. Outline statistical approaches used in meta-analyses.

3. Apply meta-analysis for post-hoc evaluation of clinical trial data.

4. Evaluate treatment effects by subgroups using individual patient data.

5. Identify the role of meta-analysis and systematic review in evaluating adverse events.

6. Explore current strategies using meta-analyses in the Marketing Authorisation process.

7. Explain the role of meta-analysis and systematic review in generating evidence- based treatment guidelines.

8. Describe the role of meta-analysis and systematic review in pharmaco-economic evaluation.

9. Outline the process of writing and publishing a meta-analysis and systematic review.

M07

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SYLLABUS MAPPING

7.1 Introduction to systematic reviews and the meta-analytic approach:• Principles of evidence-based medicine

(EBM);• Define the objective and selection

criteria of the meta-analysis;• Search for published articles in

databases (Embase, Medline, Cochrane registries, etc.) and unpublished trials;

• Carry out a literature review;• Select clinical trials to be included in the

meta-analysis;• Define the quality of clinical trials (Jadad

score, etc.);• Extract and present data; • Interpret the results.

1 7.11, 9.23, 9.25, 13.3, 13.11

7.2 The statistical approaches used when carrying out a meta-analysis:• Bayesian methods;• Fixed effects models;• Funnel plots;• Random effects models;• Regression models;• Sensitivity analyses;• Standard X² test.

2 9, 13.3, 13.11

7.3 Meta-analysis used to demonstrate an efficacy that was not the aim of clinical trials in the pre- and post-authorisation phases.

3 13.3, 13.11

7.4 Meta-analysis used to explain apparently contradictory results:• Exploring heterogeneity using examples

such as pain;• Meta-regression techniques.

3 9.23, 13.3, 13.11

M07

7.5 Using individual patient data in meta-analyses to evaluate treatment effects on different subgroups, for example age, gender, ethnicity.

4 13.3, 13.11

7.6 Meta-analysis and systematic review used in the evaluation of adverse events:• The example of statins.

5 7.15, 13.3, 13.11

7.7 Examples of meta-analyses used for MarketingAuthorisations in:• The European Union;• The United States;• Japan.

6 10.7, 10.9, 10.13, 13.3, 13.11

7.8 Meta-analysis and systematic review used as a baseline for making recommendations:• Direct treatment comparisons;• Indirect treatment comparisons (the

example of stents).

7 10.2, 13.3, 13.11

7.9 Meta-analysis and systematic reviews used for pharmacoeconomic evaluation:• Use of examples.

8 13.1, 13.2, 13.3, 13.11

7.10 Writing and publishing a meta-analysis and systematic review:• Protocols for meta-analyses;• The PRISMA checklist;• Systematic reviews for the Cochrane

Collaboration.

9 7.6, 12.6, 13.3, 13.11

M07

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M08Healthcare Marketplace & Economics of Healthcare I:Healthcare Marketplace

PharmaTrain ReferencePharmatrain Base Course Module BCM 6: Healthcare Marketplace; Economics of Healthcare, May 2012, v2.0

This module is a mandatory part of the curricular unit “Healthcare Marketplace; Economics of Healthcare”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Francisco Pimentel, MD, PhD (Medical Director,

Lenitudes SA)• José Aleixo Dias, MD, MSc (Invited Auxilliary Professor,

Health Sciences Deapartment, University of Aveiro; Medical Director, Pfizer)




M08




LEARNING OUTCOMES


1. Illustrate the life-cycle management (clinical, regulatory and marketing) of medicines.

2. Describe the processes of production and review of product information to ensure adherence to ethical and legal principles pertaining to marketing activities (Good Promotional Practice).

3. Discuss the role of patient organisations.

4. Discuss the principles & practical application of health economics and patient-reported outcomes within the pharmaceutical industry.

5. Outline the principles of health technology assessment (HTA) and its role in the supply of medicines to the marketplace.

6. Discuss the principles and practice of marketing within the pharmaceutical industry.

7. Discuss drug budget control; pricing mechanisms.

M08

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SYLLABUS MAPPING

8.1 Life-cycle management planning: extension of therapeutic claims, new formulations, new dosage schedules by peri-marketing trials, post-marketing (surveillance) studies, OTC studies and quality of life measures.

1 6.5, 13.4, 13.10

8.2 Information, promotion and education; information to patients, prescribing and patient compliance.Direct Healthcare Professional Communication (DHPC).

2 10.23, 12.1

8.3 Advertising and promotion regulations; advertising claims: ethics, control and approval; promotional materials; Codes of Practice; promotional policy & procedures; Good Promotional Practice; promotional material and product support on the basis of the Marketing Authorisation.

2 10.5, 12.2, 12.3, 12.4, 12.5

8.4 Role of patient organisations. 3 12.1

8.5 Overview of healthcare economics, health economic evaluation studies.Principles of pharmacoeconomics and evidence-based medicine.Measurement of healthcare efficiency. Governmental policy and third party reimbursement.

4 13.1, 13.2, 13.3, 13.7, 13.11

8.6 Evidence Based Medicine (EBM), Health Technology Assessment (HTA), Treatment Guidelines.

5 13.11

8.7 Quality of Life, concept and measurement instruments.

4, 5 13.4

M08

8.8 Principles & practice of marketing; market structure and competition; market analysis; medical marketing and market access.Economics of industry: competition, licensing, co-marketing.

6 13.5, 13.6, 13.8

8.9 Publication strategy; educational meetings; sponsored meetings and publications.

2, 6 12.6, 12.8

8.10 Sales representative training; material and aids.

2, 6 12.7

8.11 Drug budget control; pricing mechanisms; methods of reimbursement.

7 13.1, 13.5



M08

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M09Healthcare Marketplace & Economics of Healthcare II:Health Economics

PharmaTrain ReferencePharmatrain Course Module EXM01: Health Economics, May 2012, v2.0

This module is a mandatory part of the curricular unit “Healthcare Marketplace; Health Economics”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Jorge Simões, PhD (Invited Full Professor, Health Sciences

Department, University of Aveiro; Invited Full Professor, Hygiene and Tropical Medicine Institute, IHMT, Nova University of Lisbon; President of the Portuguese Health Regulation Authority, ERS)

• Nuno Cobrado, PharmD, MSc (Hospital Strategy Strategic Manager, Novartis)

Main Bibliography • “Health Economics”, Sloan FA, Hsieh C. The MIT Press,

2012.• “Methods for the Economic Evaluation of Healthcare

Programmes”, 3rd ed. Edited by Drummond M et al. Oxford University Press, 2005.

M09




LEARNING OUTCOMES


1. Explain the multidisciplinary nature of pharmacoeconomics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century.

2. Use in an appropriate manner the fundamental scientific theories underlying the application of health economic techniques to a range of healthcare interventions.

3. Recognise and be capable of utilising basic relationships and techniques of healthcare management to maximise benefits from a given resource.

4. Explain and present information associated with economic appraisal and assessment of new medicines carried out by NICE or similar agencies.

5. Explain the role of the agencies which police the economic viability of existing and new medical technologies.

6. Compare & contrast the different challenges of healthcare expenditure presented in different economies.

M09

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7. Outline the structure of the global drug development and regulatory framework with emphasis on risk management in the context of benefit/risk assessment and the role of pharmacoeconomics and quality-of-life, and be capable of explaining its evolution, strengths & weaknesses.

8. Explain methods utilised in clinical trials for examining cost-effectiveness of new pharmaceutical products.


SYLLABUS MAPPING

9.1 Economics of industry and corporate finance:• pharmaceutical development

strategic planning and the role of pharmacoeconomics;

• product life-cycle management / re-positioning and the role of pharmacoeconomics.

Drug budget control methods.Pharmaceutical pricing mechanisms.Financial management and the accounting framework:• organisation of the finance department;• internal control, forward planning. Cost of management of clinical trials.Budgeting and cost behaviour.

1, 2, 7, 13.8, 13.9, 13.10

9.2 Principles of health economics:• overview of economic theories;• global understanding and approach to

‘Macro’ & ‘Micro’ economics;• supply and demand concept;• economic margin of benefits;• sustainable economic environment;• money, cost, resource, input and output,

trade-off;

2, 3, 6 13.1

M09

• scarcity, opportunity cost;• utility judgement;• role of ‘Need’ as an alternative

distribution mechanism to ‘Demand’.Priority setting in healthcare and the reasons for it:• economic objectives of healthcare;• allocative vs. technical efficiency.Constraints on clinical freedom:• principles of common good;• social ethics and utilitarianism, and

potential conflicts between medical ethics and economics.

9.3 Economic evaluation in healthcare: review of the four (4) main techniques of economic evaluation in healthcare (cost minimisation, cost-benefit, cost-effectiveness and cost-utility analyses).Reasons why each economic evaluation is used in their appropriate situations and types of studies (clinical trials; naturalistic) suitable for economic evaluations.Review of alternative criteria for choice; margin & efficiency as a social goal.Current methodological controversies and consideration of practical difficulties encountered in the actual conduct of economic evaluation studies.

2, 4, 7, 8 13.7, 13.11

9.4 Pharmacoeconomic theory:• approaches to the evaluation of

pharmacoeconomics;• hierarchy of evidence;• measuring outcomes for drug

interventions.Outcome research (effectiveness & efficiency) vs. clinical research and controversies surrounding outcomes research.

2, 7, 8 13.2, 13.3, 13.7

M09

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Utility theory and methods of measuring utility including multi-attribute utility theory.When is utility measurement appropriate? Quality Adjusted Life Year (QALY) and Healthy Year Equivalent (HYE).

9.5 Application of pharmacoeconomic theory:• pharmacoeconomic methodological issues

and external vs. internal validity;• application of results to different

settings;• use of models and their appropriateness;• decision analysis in modelling and

sensitivity analysis.Different approaches to reimbursement for medicines in EU and the role of Health Technology Assessments (HTAs).Similarities and differences between Regulatory and HTA agencies.Drug development prioritisation decisions. Indirect costs and outcomes.Willingness to pay.Use of statistics in pharmacoeconomic evaluation including systematic review and meta-analysis.Design of pharmacoeconomic studies:• general principles and types of studies;• purpose and application of

pharmacoepidemiology in economic studies of drugs.

Health-related quality of life (HRQoL) studies:• how is HRQoL measured?• methodological consideration in HRQoL

measurement;

2, 4, 5 13.2, 13.4, 13.7, 13.8, 13.11

M09

• non-utility HRQoL studies, practical considerations, interpretation of score changes, examples of generic and disease-specific instruments, choice of HRQoL instruments in naturalistic and controlled studies.

Policy implications of pharmaceutical resource allocation league tables in healthcare.

9.6 Medical marketing and market access:• market forces, market dynamics,

production and distribution of outputs.• reason for market failure (uncertainty,

monopoly power, problems of competition and externalities).

The nature of the commodity ‘Healthcare’:• how and to what extent ‘Healthcare’

differs from other market goods;• challenges to consumer sovereignty;• role of the concept of agency in

healthcare; doctor as a perfect agent; public good and merit argument;

• healthcare in the marketplace.

1, 3, 5, 6 13.6, 13.8

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DETAILS OF EACH CURRICULAR UNIT OPTIONAL CURRICULAR UNITS

Code Title

O01 Project Management in Medicines Development

O03 Medical Writing and Communication

O04 Managing an R&D Project

O05 Informatics in Medicine and Clinical Research

O06 Translational Medicine

O07 Medical Affairs

O08 Statistics Applied to Clinical Research

O09 Quality Management and Inspections

O11Ethics in Clinical Research: Practical Approach to Ethical & Legal Aspects of Clinical Trials

O12 Principles and Practices of Medical Device Development

OPT

ION

AL

CUR

RIC

ULA

R U

NIT

S

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O01Project Management in Medicines Development

PharmaTrain ReferencePharmatrain Course Module ELM 3: Project Management in Medicines Development, Jan 2012, v1.0

This module is an optional part of the curricular unit “Project Management In Medicines Development”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • James Potter, BSc, MBA (Project Management Faculty,

University of Virginia, USA)• Sandra Lang, MSc (Project Management Director,

PharmaNet/i3, Germany)

Main Bibliography • “Harvard Business Essentials: Managing Projects Large

and Small: The Fundamental Skills for Delivering on Budget and on Time”. Harvard Business School Press, 2004.

• “Manager’s Toolkit: The 13 Skills Managers Need to Succeed”. Harvard Business School Press, 2004.


6 ECTS.

O01

LEARNING OUTCOMES


1. Define a project; define differences in organisational structures as well as their impact on leading a clinical development project.

2. Define, plan, manage and verify the scope of medicinal product development.

3. Review the Project Management Body of Knowledge (PMBOK) framework.

4. Identify the processes required to plan successfully, execute, monitor and control as well as close-out a complex clinical trial.

5. Estimate the resource needs and sequencing activities to produce a project schedule (Network Diagram and Gantt Chart).

6. Estimate and control budgets for the medicines development plan.

7. Discuss human resources management and communication in complex clinical trial projects.

8. Evaluate risk management and contingency planning in medicines development.

9. Analyse clinical study inspection findings and relate these to project monitoring, controlling, risk management and quality management.

10. Identify and assess factors in failing clinical trials; discuss the concept of project rescue.

O01

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O01 CURRICULUM CONTENT LEARNING OUTCOMES MAPPING

SYLLABUS MAPPING

1.1 Why Project Management? 1 2.1, 2.3, 2.4, 2.5, 2.6, 4.1, 7.9

1.2 Review of Project Management Body of Knowledge (PMBOK) Framework.

3 7.9

1.3 Integration management concepts. 1, 4 7.9

1.4 Scope management; scheduling. 2, 4 2.3, 2.4, 2.6, 5.1, 5.4, 6.2, 6.3, 6.4, 6.5, 7.6, 7.9, 10.5, 10.13, 10.21

1.5 Quality management in complex international clinical trial projects.

9 2.2, 7.18

1.6 Human resources & communication management; team management and leadership skills in clinical projects.

5, 7 2.6, 2.7

1.7 Communication and stakeholder management.

7 7.9

1.8 Budgeting and controlling; resource estimating and budget management respecting national differences in healthcare systems; procurement.

5, 6 5.4, 6.3, 6.4, 7.9, 7.10, 7.12, 7.14, 7.16

1.9 Project management: disaster avoidance vs. project rescue.

8, 10 7.7, 7.8, 7.9, 7.12, 7.13, 7.16

1.10 Clinical study inspections: findings and relationship to monitoring, controlling, risk management and quality management.

9 2.2, 7.17, 7.18, 10.5, 10.10

1.11 Case Study 1: Protocol Presentation. 2 7.1, 7.6

O01

1.12 Case Study 2: Risk Analysis and Risk Management Plan.

8, 10 7.9, 7.10, 7.12, 7.14, 7.15, 7.16, 7.18, 10.21

1.13 Case Study 3: Stakeholder Analysis and Communication Plans.

7 7.9, 7.12

1.14 Case Study 4: Human Resources Management; Responsibility; Assignment Matrix.

7 7.9

1.15 Case Study 5: Contract Evaluation; Vendor Comparison and Selection.

1, 2, 5, 6, 7

7.10

O01

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O03Medical Writing and Communication

This module is a mandatory part of the curricular unit “Medical Writing and Communication”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Julia Klaproth-Forjanic, PhD (Invited Auxiliary Professor,

Health Sciences Department, University of Aveiro; C.E.O. and Senior Partner, Trilogy Writing and Consulting GmbH)

• Luís Almeida, MD, PhD (Director of the Training Programme in Pharmaceutical Medicine; Invited Associate Professor, Health Sciences Department, University of Aveiro; Managing Partner, Blueclinical Ltd.; Managing Partner, ARC Publishing; C.E.O, Luzitin S.A.)

Main Bibliography • “Mastering Scientific and Medical Writing”. Silvia M

Rogers, ed. Springer, 2007.• “Successful Scientific Writing”. Janice R Mathew and

Robert W Mathews, ed. Cambridge University Press, 2008.


6 ECTS.

O03

LEARNING OUTCOMES


1. Possess the basic writing skills and know how targeting the audience.

2. Know how to present data from clinical research.

3. Strategically plan data publication.

4. Successfully write scientific manuscripts.

5. Prepare effective poster presentations.

6. Prepare and present effective oral communications.


SYLLABUS MAPPING

3.1 Mind the reader:• Writing skills;• Document types;• Scientific style;• Choose message and audience (be kind

to the reader).

1

3.2 Effective writing: simple and direct English:• Principles of effective writing;• Structural elements: lists, flowcharts

and subheadings;• Cut the unnecessary text;• Other writing tricks.

1

3.3 Effective writing: active voice and verbs• Active voice versus passive voice;• Use “I” and “We”;• Verbs and not nouns;• Good grammar and common pitfalls.

1

O03

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3.4 Structure and organization (sentence and paragraph level)• Punctuation;• Parallelism;• How to structure thought;• Micro-structure: Paragraphs.

1

3.5 Writing process:• Macro-structure;• Writing Process (Preparation; Writing;

Revision).

1

3.6 Data presentation:• Tables;• Flow-charts;• Graphs.

2

3.7 Publication strategy:• Audience;• Choice of journal;• Coordinating publications.

3

3.8 Scientific manuscripts:• Preparing to write an original research

manuscript;• Instructions and guidelines;• Sections of original research

manuscripts;• Other types of manuscripts.

4

3.9 Peer-review process:• Submission process;• Peer-review process;• Review outcomes;• Reply to editor’s feedback.

4

3.10 Posters and oral presentations:• Effective posters (Posters Do’s and

Dont’s);• Effective oral communications

(Structure; Length; Format; Audience; Body; Voice; Style).

5, 6

O03

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O04Managing an R&D ProjectThis module is a mandatory part of the curricular unit “Managing an R&D Project”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders• Carlos Pinho, PhD (Professor, Department of Economics

and Industrial Management, University of Aveiro)• Sérgio Simões, PharmD, MSc, PhD (Associate Professor,

Faculty of Pharmacy, University of Coimbra; Vice-President of Bluepharma S.A.; Chairman, Luzitin S.A.; Chairman, Treat U S.A.; Managing Partner, Blueclinical Ltd.)


6 ECTS.

Main Bibliography • “From Alchemy to IPO: The Business of Biotechnology”.

Robbin-Roth C. Basic Books, 2001.• “The Business of Healthcare Innovation”, 2nd ed.Burns

LR. Cambridge University Press, 2012.

O04

LEARNING OUTCOMES


1. Know the strategies to transform knowledge into value in the knowledge-based economy.

2. Define intellectual property and understand the patenting system.

3. Describe how a new technology can turn into a product and how a product reaches the market.

4. Define entrepreneurship within different contexts and identify the characteristics of an entrepreneur.

5. Define and apply the concept of innovation.

6. Knows how to prepare a business plan.

7. Knows the basics financial concepts and the legal and administrative aspects related to the creation of a start-up company.

8. Understand the objectives of business incubators and their role in the starting-up phase.


SYLLABUS MAPPING

4.1 Knowledge valorisation. 1

4.2 Intellectual property protection. 2

4.3 From technology to product and from product to market.

3

4.4 Entrepreneur versus Manager: competences and skills.

4

4.5 Innovation: Problem Statement and elevator Pitch.

5

4.6 Finance basics for entrepreneurs. 7

O04

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4.7 Financing sources and internationalization in the healthcare sector.

7

4.8 Business incubators. 8

4.9 Presentation of a business idea. 8

4.10 Academic start-ups. 8

4.11 Business plan. 6

4.12 Problem Statement and elevator Pitch. 6

4.13 Market research. 6

4.14 Creation of value using the marketing mix: specificities of the Healthcare sector.

1

4.15 Marketing strategies for start-up companies.

7

4.16 Value proposition and next steps in business development.

6

O04

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O05Informatics in Medicine and Clinical Research

This module is a mandatory part of the curricular unit “Informatics in Medicine and Clinical Research”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Nelson P. Rocha, PhD (Full Professor, Health Sciences

Department, University of Aveiro; Clinical Research Office Director, Health Sciences Department, University of Aveiro)


6 ECTS.

Main Bibliography • “Clinical Research Informatics (Health Informatics)”.

Richesson RL & Andrews JE. Springer, 2012.• “Electronic Health Records for Dummies”. Williams T &

Smarth A. Wiley Publishing, 2010.

O05

LEARNING OUTCOMES


1. Identify the technologies, systems and architectures being used within medical and clinical research applications.

2. Know the specificities of the development lifecycle of an information system.

3. Understand the interoperability concerns and to know the actual developments and existing standards.

4. Evaluate the possibilities associated with the new cloud-computing paradigm.

5. Understand the architectures of the electronic health record systems and to anticipate theirs future evolutions.

6. Understand the foundations of the systems to support the clinical decision-making.

7. Evaluate and discuss the issues related with the use of healthcare data for medicines surveillance and research.

8. Know text-mining techniques for knowledge extraction in medicine.

9. Evaluate and discuss the impact of the information society in citizen’s daily life.


SYLLABUS MAPPING

5.1 Informatics fundamentals (historical perspective)

• Technology: computer systems, communication networks, the future;

• Clinical applications: imaging, telemedicine, health records, decision support.

O05

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5.2 Sociological perspective: the impact of the information society in the citizens’ daily health concerns and expectations• Relationship between ICT, users, health

professionals and technological health information management networks;

• ICT impact on health uses, representations and its relationship with the Portuguese population ;

• ICT presence in health: Online research on health subjects: what does it mean?;

• Place and role of Internet research about health, aesthetics and well-being;

• Health reference sources - ICT, users and health professionals.

5.3 Information and communication technologies• Past, Present and Future of

Information;• Communications Technologies;• Communications Concepts;• Information Systems Architectures;• Security and Trust Establishment.

5.4 From paper to Electronic Health/Medical Records and beyond• Generation of clinical information;• eHealth - a healthcare transformation;• Electronic Health/Medical Record: Past,

present and future;• Architectures and interoperability;• Regional and national telematics health

networks;• Patient empowerment and the Personal

Health Records.

O05

5.5 Information system lifecycle• Principles of information systems;• Information systems development

process;• Visual modelling;• Participatory design and verification;• Current paradigms for information

systems deployment and human-computer.

5.6 Interoperability• Standards development history and

current process;• Data standard and data sharing;• Transaction standards;• Nomenclatures, vocabularies, and

terminologies;

• Ontologies and taxonomies;• Interoperability standards;• HL7 architecture.

5.7 Support to clinical decision making• Clinical decision making and care

process improvement;• Clinical decision support: the nature and

cognitive aspects of decision making, decision support tools, transformation of knowledge into clinical decision support tools;

• Evidence-based patient care: evidence sources; evidence grading, clinical guidelines, implementation of guidelines as clinical algorithms;

• Clinical workflow analysis, process redesign, and quality improvement;

• Imaging: a special case.

O05

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5.8 Cloud computing in medicine• Cloud Computing Technologies;• Applications;• Economic Aspects - Business Models;• Trust and Data Privacy;• Interoperability with Healthcare

Standards;• Case study – Medical Imaging Networks;• Future directions.

5.9 Use of healthcare data for medicines surveillance and research• Functional requirements of data

repositories;• Clinical research and healthcare data

quality and integrity;• Leveraging observational data to

support active medical product surveillance and outcomes research.

5.10 Text mining and knowledge extraction in health• Methods for information retrieval;• Main concepts in information extraction;• Applications in medicine;• Case-study: the EU-ADR project.

5.11 Case Studies: successful and unsuccessful stories

O05

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O06Translational Medicine

This module is a mandatory part of the curricular unit “Translational Medicine”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Paulo Fontoura, MD, PhD (Invited Associate Professor,

Health Sciences Department, University of Aveiro; Head of Translational Medicine CNS, F. Hoffman-La Roche, Basle, Switzerland)

• Carlos Faro, PharmD, PhD (President, BIOCANT)

Main Bibliography • “Principles of Translational Science in Medicine:

From Bench to Bedside”. Wehling M & Marincola FM. Cambridge University Press 2009.


6 ECTS.

O06

LEARNING OUTCOMES


1. Understand the concept of translational medicine, its scope and its present status.

2. Know the current challenges in translational science and its research pathways.

3. Know what translational medicine can and cannot do as well as the concepts of primary and secondary translational medicine.

4. Realize the importance of the “omics technologies” in translational medicine.

5. Know how cellular products, pharmacogenetics, biobanks, experimental surgery and medical engineering can lead to target identification.

6. Know what a biomarker is and their different classes.

7. Understand the function of a biomarker and its validation process.


SYLLABUS MAPPING

6.1 Translational medicine & biomarkers in Neurology and Psychiatry: challenges & opportunities

6.2 The dawn of translational medicine• Primary and secondary translation;• The scope of translational medicine;• What translational medicine can and

cannot do.• The present status of translational

medicine.• Current challenges of translational

science in medicine.• Changes in education for Translational

Medicine

1

O06

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6.3 Target identification and validation• “Omics” translation and “omics”

technologies.• Cellular products.• Tissue biobanks.• Translational pharmacogenetics.• Biomarkers in the context of health

authorities and consortia• Human studies as a source of target

information.• Target profiling in terms of

translatability and early translation.

4, 5, 6

6.4 Biomarkers• Biomarkers as the most important

contributors to translational medicine.• Classes of biomarkers.• Biomarkers development and validation.• Recent FDA initiatives.• Research biomarkers.• Toxicity biomarkers.• Pharmacogenetic biomarkers.

6

6.5 Examples of translational biomarkers• Translational Regenerative Medicine -

application to stem cells therapies and tissue engineering products

• Biomarkers in oncology.• Translational imaging research.• Cardiovascular biomarkers.• Learning by experience: example of a

successful and a failed translational process

6

6.6 Targeted clinical trials• Biomarkers and surrogate endpoints for

safety and efficacy.

6

O06

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O07Medical Affairs

This module is a mandatory part of the curricular unit “Medical Affairs”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Ana Maria Nogueira, MD (Invited Auxiliary

Professor, Health Sciences Department, University of Aveiro; President of the Board of the Competence in Pharmaceutical Medicine, Portuguese Medical Association; Medical Director, MSD)





6 ECTS.

O07

LEARNING OUTCOMES


1. Know the roles and responsibilities of Medical Affairs and main trends regarding organizational structures within pharmaceutical companies.

2. Understand the Medical Governance principles and strategic alignment with business goals.

3. Know the main activities under the scope of Medical Affairs.

4. Learn how to develop Medical Affairs Plans and Performance Metrics for Medical Affairs activities.

5. Apprehend the Ethical and Compliance Principles applicable to Medical Affairs.

6. Understand objectives and guiding principles for scientific communications and scientific leader engagement.

7. Understand Advisory Boards’ objectives, planning and management.

8. Learn the specificities of developing Local Medical Research Initiatives.

9. Understand the value, framework and management of Research Partnerships.

10. Learn the different types and apprehend best practices regarding the organization of Continuous Medical Education events.

11. Understand the importance of promoting a Publication mind-set and learn how to develop a local Publication strategy.

12. Learn the principles for Good Promotional Practices.

13. Know the different types of medical inquiries and understand the role of Medical Scientific Services.

14. Globally apprehend the value and scope of Medical Affairs in today’s Healthcare community.

O07

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15. Know the roles and responsibilities of Medical Affairs and main trends regarding organizational structures within pharmaceutical.


SYLLABUS MAPPING

7.1 Understanding medical affairs• Pharmaceutical Medicine and

Pharmaceutical Industry: as trategic partnership between Science and Business.

7.2 Medical governance• The Medical Framework - Medical Affairs,

Clinical;• Research, Regulatory Affairs and

Pharmacovigilance;• Partnering with Business;• The importance of a global alignment;• Leadership, Teamwork and Cross-

Functional Collaboration.

7.3 Medical affairs activities• Definitions;• Medical Affairs Plans;• Objectives and Metrics;• Ethics and Compliance.

7.4 Communicating science• Who, how and when?• Engaging with scientific leaders;• Understanding new stakeholders;• Building trust and credibility.

7.5 Local medical research initiatives• The Value of Real World data;• Health Education Research Projects;• Measuring Capabilities and resource needs;• Developing Metrics and milestones;• Filling local data gaps for reimbursement

files.

O07

7.6 Research partnerships• Pre-clinical Research;• Translational Research;• Clil Research.

7.7 Good promotional practices• Medical review – the importance of

teamwork and good communication;• Scientific references – a critical component;• Basic rules and Standard Operating

Procedures.

7.8 Advisory boards• Strategic, Operational and Ethical

Standards;• “Voice of the Customer” & “Voice of the

Business”.

7.9 Medical scientific services• A Key Scientific Service;• Setting Objectives and Quality Standards;• Medical Inquiries – How to ensure Tracking

and Oversight.

7.10 Continuous medical education• Quality, Ethical and Compliance Standards.

7.11 Publications• Local Publications - The ultimate goal for

Clinical Projects;• Promoting a local publication mind-set;• How to develop a Publication Strategy;• Know the literature & be an expert.

7.12 Medical affairs in the healthcare community: present and future

• The growing value and scope of Medical Affairs in Today’s Healthcare community: a Strategic Outlook.

O07

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O08Statistics Applied to Clinical Research

This module is a mandatory part of the curricular unit “Statistics Applied to Clinical Research”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Pedro Sá Couto, PhD (Professor, Mathematics

Department, University of Aveiro; Clinical Research Office, Health Sciences Department, University of Aveiro)

• Vera Afreixo, PhD (Professor, Mathematics Department, University of Aveiro; Clinical Research Office, Health Sciences Department, University of Aveiro)

Main Bibliography • Cleophas, Ton; Zwinderman, Aeilko. Statistics Applied to

Clinical Studies. 5th edition. Springer, 2012.• Howell, David: Statistical Methods for Psychology. 4th

Edition. New York: International Thomson Publishing Company, 1997.

• Kirkwood, Betty; Stern, Jonathan. Essentials of Medical Statistics. 2nd edition. New York, Blackwell Publishing Limited, 2001.

• Zar, Jerrold. Biostatistical analysis. 4th Edition. London: Prentice-Hall, 1999.


6 ECTS.

O08

LEARNING OUTCOMES


1. Explore data analytically and graphically.

2. Compare averages and frequencies: Two sample tests; parametric and non-parametric tests.

3. Analyse results from different ANOVA types: between-subjects factorial experiments; within-subjects experiments; mixed factorial experiments; post-hoc multiple comparison tests; non-parametric ANOVA tests.

4. Measure statistical association: Pearson; Spearman’s rank; and chi-squared test for association.

5. Measure intra- and inter-rater reliability: Kendall’s tau; Cohen’s kappa; intraclass correlation coefficient.

6. Applying statistical methods based on linear regression: Significance testing; residuals analysis; dummy variables.

7. Applying statistical methods based on logistic regression: Logit equation and logistic regression function; binary and multinomial; interaction between variables.

8. Explore survival analysis results: Survival functions; comparison of clinical life tables and Kaplan-Meier method.

9. Power analysis and sample size estimation.

O08

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x y


SYLLABUS MAPPING

8.1 • Basics concepts;• Why should we study Biostatistics?• Measurements and data;• Population and samples;• Theoretical distributions: Normal

distribution and others;• Statistical inference;• Statistical hypothesis;• Statistical power and sample size;• Choosing a statistical test.

8.2 • Exploring data;• Describing data: measurements of

location;• Describing data: measurements of

variability;• Moderate and severe outliers and

extreme values;• Missing data handling;• Displaying data graphically.

8.3 • Testing group differences for significance;

• One sample tests;• Tests for comparing two independent

samples;• Tests for comparing two paired samples;• Tests for one-factor between subjects

experiment;• Tests for one-factor within subjects

experiment;• Tests for two-factor subjects

experiments (between, within, and mixed.

O08

8.4 • Measuring strength between variables;• Testing for association in quantitative or

ordinal data;• Testing for association in nominal data;• Testing for association between

qualitative and quantitative variables;• Measures of agreement and reliability.

8.5 • Prediction of group scores or categories;• Introduction to regression analysis;• Linear regression;• Logistic regression: binary, multinomial

and ordinal data;• Regression of counts.

8.6 • Survival analysis;• Analysis of rate and survival time;• Censored data;• Kaplan-Meier estimator;• Comparing survival functions;• Cox proportional-Hazards regression

model.

O08

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O09Quality Management and Inspections

PharmaTrain ReferencePharmaTrain European Master of Regulatory Affairs, Syllabus July 2012

This module is a mandatory part of the curricular unit “Quality Management and Inspections”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders• Fernanda Ralha, PharmD (Director, Licensing and

Inspection Directorate, INFARMED - National Authority of Medicines and Health Products, I.P.)

• Mónica Galo, PharmD (Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Quality Assurance Development Manager, Novartis)

Main Bibliography • “A Practical Guide to Quality Management in Clinical

Trial Research”. Ogg G, CRC Press, 2005.


6 ECTS.

O09

LEARNING OUTCOMES


1. Discuss, interpret and apply the principles and key elements of a quality management system and understand its role in ensuring compliance with GxP.

2. Assess and discuss how a quality management system contributes to good regulatory practices in industry and Competent Authorities.

3. Understand and apply Quality Risk Management / Quality by Design and its impact on regulatory (in-house and regulatory authorities) decision making.

4. Describe the purpose and scope of inspections by Competent Authorities, and the prerequisites for inspection readiness.

5. Understand how inspections contribute to make key elements of a quality management system robust, ensure compliance with GxP, ensure protection of patients’ safety, rights and integrity, as well as data integrity, environmental protection and animal welfare as laid down in GxP regulations.

6. Discuss and develop a strategy for the involvement of Regulatory Affairs in audit and inspection follow-up and how to prepare and implement a corrective and preventive action plan.

7. Discuss and describe the similarities and differences of GCP, GLP, GMP and QA/QC standards and processes in pharmacovigilance.

8. Understand and develop a risk / issue management and business continuity plans for a given area, address cross-functional challenges and develop a holistic communication strategy.

O09

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SYLLABUS MAPPING

9.1 Quality Management Principles: • Evolution and scope;• Models and standards;• Design and implementation of a QM

system (QMS);• Change management strategies when a

QMS is introduced / updated;• Development of SOPs;• Training of/with SOPs;• Knowledge management and its

documentation;• Quality Risk Management/Quality by

Design;• Delegation of tasks versus delegation of

responsibility.

1, 2, 3, 4, 6

9.2 Quality assurance (QA) and quality control (QC) in the pharmaceutical industry:

• Pharmaceutical development and manufacturing;

• Preclinical development;• Clinical development;• (Bio) Laboratories;• Pharmacovigilance;• Data Management;• Audits and CAPAs;• Electronic systems, including

Computerized Systems Validation (CSV).

1, 2, 6, 7

9.3 Inspections:• QM/QA (Inspectorates – Sponsor);• PIC/S (Pharmaceutical Inspection

Convention and Co-operation Scheme);• Quality Manuals;• European GMP inspections;• European GCP inspections;• European Pharmacovigilance

inspections;

4 & 5

O09

• European GLP inspections and joint OECD inspections;

• Roles of the EMA and the national competent authorities;

• EU formats for Inspection Reports;• FDA inspections and joint FDA/ EMA/

EU- MS inspections.

9.4 Risk and crisis management:• Quality risk management according to

ICH Q9 and in clinical research;• Incident management and contingency

planning;• Business continuity plans;• Managing the GxP and

Pharmacovigilance interface in a recall situation;

• Issue management and communication with regulatory bodies and other stakeholders;

• Managing communication with the public at large.

8

O09

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O11Practical Approach to Ethical and Legal Aspects of Clinical Trials

PharmaTrain ReferencePharmatrain Course Module ELM 8: Practical Approach to Ethical & Legal Aspects of CTs, January 2012, v1.0

This module is a mandatory part of the curricular unit “Practical approach to ethical & legal aspects of CTs”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • António Faria Vaz, MD, MSc (Invited Auxiliary Professor,

Health Sciences Department, University of Aveiro; Head of Ethics Committee, ARS Lisboa e Vale do Tejo; Head of Pharmacy and Therapeutic Committee, ARS Lisboa e Vale do Tejo)

• Antonio Lourenço, MD (Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Member of the Executive Committee of the National Ethics Committee for Clinical Research, CEIC; Member of Pharmacy and Therapeutic Committee, ARS Lisboa e Vale do Tejo)

Main Bibliography • “Ethical Issues in Clinical Research: A Practical Guide”.

Edited by Bernard Lo, Lippincot Williams & Wilkins, 2009.

O11


6 ECTS.

LEARNING OUTCOMES


1. Appraise the consequences of the history of the development of ethical standards in biomedical research.

2. Enable and manage the appropriate ethical and legal environment for the performance of a clinical trial.

3. Identify and manage the ethical conflicts and issues in a particular clinical trial, including studies utilising modern technologies.

4. Discuss the need for ICH-GCP conformity as a prerequisite for the ethical conduct of clinical trials.

5. Plan, prepare and follow-up the outcome of the ethical review process by ethics committees.

6. Perform a comprehensive risk/benefit assessment of a clinical trial.

7. Define, prepare and supervise an informed consent process appropriate to the needs of the research participants in a specific biomedical research setting.

8. Identify and mitigate the risk of misconduct and fraud in biomedical research.

9. Assess the suitability of the environment for confidentiality and data protection in clinical trials.

10. Recognise and deal with vulnerable populations.

O11

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SYLLABUS MAPPING

11.1 Philosophical models for biomedical research ethics; Consequences of the evolution of biomedical research ethics: • Nuremberg Code; • Declaration of Helsinki; • Belmont Report; • Council of Europe: Convention on

Human Rights; • ICH-GCP; • Directive 2005/28/EC; Directive

2001/20/EC.

1 8.1, 8.2, 8.4

11.2 Ethical and legal requirements for clinical trials:• Sponsor & investigator responsibilities

and suitability; • Sponsor-Investigators’ obligations in

Investigator-initiated Trials; • Clinical trial approval by Competent

Authority and favourable opinion of ethics committee(s);

• Contractual obligations of sponsors with investigators, hospitals & vendors;

• Insurance coverage for participants, investigators and sponsor;

• Informed consent; • Safety data collection, assessment and

reporting;• Clinical trial registration & final

reporting.

2 7.4, 7.9, 7.10, 7.11, 7.15, 7.17, 7.18, 7.19, 8.3, 8.4, 8.9, 8.11, 10.1, 10.5, 10.10, 10.19, 11.2, 11.3, 11.4, 11.5,

O11

11.3 Ethical conflicts in clinical trials:• Ethical values in drug development;• Conflicts of interest of all involved

stakeholders;• Need for equipoise;• Placebo and comparator treatment;

randomisation;• Blinding;• Protection of participants’ interests;• Advertisement for participants;

3 4.5, 7.1, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 8.12, 8.13, 8.14, 8.15, 8.16, 13.1

• From compensation to inducement;• Access to diagnosis and treatment;• Risk, benefit and burden of

participation;• Informed consent process;• Follow-on treatment;• Level of animal data requirements for

First-in-Man studies;• In embryonic and stem cell research.

11.4 ICH-GCP conformity as a prerequisite for the ethical conduct of clinical trials:• Ethical issues in study and protocol

design; • Risk/benefit assessment;• Investigator brochure and update;• Quality assurance and quality control in

clinical trial management;• Documentation processes;• Quality of Investigational Medicinal

Products.

4 7.1, 7.4, 7.5, 7.6, 7.14, 7.15, 7.16, 7.17, 7.18, 8.3, 8.8, 10.4, 10.5, 10.10

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11.5 Ethical review process:• The role, constitution and processes of

ethics committees;• Ethical review systems in ICH Regions;• The ethical review submission dossier in

multinational clinical trials;• Ethical review, transparency and

outcome;• Ethical review and capacity-building in

developing countries;• Quality management of ethics

committees.

5 7.4, 7.18, 8.2, 8.3, 8.16, 10.5, 10.8, 10.10

11.6 Risk / benefit assessment concerning:• Type of medication and intervention;• Medicine’s development status;• Patient population;• Clinical trial design; • Investigator and site suitability;• Role and responsibilities of Data Safety

Monitoring Boards.

6 7.1, 7.2, 7.3, 8.3, 8.8, 8.9, 8.13, 8.14, 8.15, 11.3

11.7 Information to participants and consent process:• Participant information and consent

format, tools and process; • Healthy volunteers and adult conscious

patients;• Emergency situations and unconscious

patients;• Very old patients and patients with

dementia;• Paediatric populations;• In clinical trials in developing countries;• In clinical trials with genetic information

collection;• In clinical trials with medical devices;• In clinical trials with advanced therapies;• In registries and bio-banks;• Information on clinical trials to &

between patients in Social Networks.

7 8.9, 8.14, 8.15, 8.16

O11

11.8 Misconduct and fraud in biomedical research:• Definitions;• Identification tools;• The whistleblower conflict;• How to deal with misconduct and fraud

in biomedical.

8 8.17

11.9 Confidentiality and personal data handling and protection:• European data protection rules;• Practical issues of data protection in

clinical trials;• Data protection in clinical trials

generating genetic information;• Data protection rights of patients

donating tissues.

9 8.10, 8.13

11.10 Ethical issues in vulnerable populations:• In clinical trials of orphan medicines;• In clinical trials in paediatrics;• In clinical trials with pregnant and

lactating women;• In clinical trials with unconscious and

mentally impaired patients;• In clinical trials in developing countries; • Informed consent and therapeutic

nihilism in a geriatric patient population.

10 8.9, 8.12, 8.14, 8.16

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O12Principles and Practices of Medical Device Development

PharmaTrain ReferencePharmaTrain Elective Module 11, March 2013, v2.0

This module is a mandatory part of the curricular unit “Principles and practices of medical device development”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

Module Leaders • Bruno Gago, PharmD, PhD (Deputy Director, Training

Programme in Pharmaceutical Medicine, Invited Auxiliary Professor, Health Science Department, University of Aveiro)

• Judite Neves, PharmD (Director of Health Products Directorate, INFARMED - National Authority of Medicines and Health Products, I.P.)

Main bibliography • “The Medical Device R&D Handbook”, 2nd ed. Kucklick

TR, CRC Press, 2012.• “Medical Device Development: Regulation and Law”, 2nd

ed. Kahan JS, & Meyers R, Parexel Intl Corp, 2009.


6 ECTS.

O12

LEARNING OUTCOMES


1. Describe and define the field of medical devices, the distinguishing features of medical device technologies, industries and regulatory framework as compared to medicinal products.

2. Interpret the conformity assessment of medical devices based on essential requirements.

3. Categorise medical device products according to the relevant classification and demarcation principles.

4. Describe and illustrate non-clinical and clinical development of medical devices, standardisation and use of standards: European standards, national standards, ISO/IEC standards and harmonised standards. Quality management.

5. Appraise the vigilance and risk management programmes for medical devices.

6. Interpret the principles underlying the compilation of technical dossier/design dossier.

7. Appraise the combined pharmaceutical, clinical pharmacological and technological requirements for the development of medicine-medical device combinations.

8. Evaluate the need and requirements for the joint development of targeted medicine therapy and the related companion diagnostics.

9. Assess the medical needs and clinical significance of emerging technologies.

10. Estimate the requirements for the Health Technology Assessment of medical devices.

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SYLLABUS MAPPING

12.1 Introduction to medical device development & regulation

• The definition and classification of medical devices & demarcation from other products;

• Peculiarities of a medical device: technologies, life-cycle, development, continuous improvement through iteration, market size, market growth, major players & competition.

4, 6, 9, 10

12.2 Strategy of development of medical devices

• Innovation versus Modification: Development & Design;

• Quality of medical devices;• Non-clinical & clinical development in

relation to product & type;• Assessment (HTA) & Appraisal.

4, 10

12.3 Generation of clinical evidence• Clinical data collection - in relation to

product & type – observational studies & interventional clinical trials;

• Post-marketing surveillance plan including post- marketing clinical follow up;

• ISO 14155 (GCP for medical devices).

3, 4, 7

12.4 Benefit / risk assessment• Performance assessment;• Technical Dossier & application for CE

mark according to class;• Health Technology Assessment (HTA);• Clinical evaluation.

2, 3, 5, 7, 10

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12.5 Case studies• Exercises of classification &

demarcation of products;• Examples of CE applications:

o medical devices;o medicinal products;o types & characteristics of medicines-

medical device combination products;o drug delivery systems;o in vitro diagnostics.

12.6 Emerging technologies & their specific regulation

• Active Implantable Medical Devices Directive (AIMD) & relevant regulations;

• Strategy for combined development & evaluation of medicines & medical device combination products integrated medicines-medical devices;o EMA/CAT-NB (European Medicines

Agency/Committee for Advanced Therapies & Medical Devices Notified Body) Collaboration Group;

o Cooperative Ethical evaluation.• Use of animal tissues within medical

devices;• In vivo, in vitro & companion

diagnostics;• Nanotechnologies.

4, 7, 8, 9, 10

12.7 Case Studies on emerging technologies• Combination product: device/medicinal

product considering primary & secondary action.

• Medical device impacted upon by several Directives.

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12.8 Regulatory requirements for Medical Devices

• Basis of the European regulatory requirements for Medical Devices. Medical Devices Expert Group & subgroups (MDEG);

• Global approaches: US, Japan and ROW;• Global Harmonisation Task Force (GHTF)

& subgroups.

2, 5, 6

12.9 Fundamentals of the European Medical Device Regulations

• Active & general medical devices, in vitro diagnostics (IVD);

• MEDDEV -Guidelines, interpretation & Administrative Rules;

• The role of Notified Bodies, Accreditation Bodies & Competent Authorities.

2, 7, 8, 9

12.10 Case studies• Compilation of a Technical Dossier.• Compilation of clinical data (for clinical

evaluation).

12.11 Quality management systemSystems to be implemented & applied for

marketing & controlling Medical Devices:• Quality Management System (ISO

9001);• Medical devices - Quality management

systems - Requirements for regulatory purposes (ISO 13485);

• Risk Management for Medical Devices (ISO 14971);

• FDA Quality System Regulation.

4, 5

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12.12 Safety of medical devices, vigilance systems for medical devices

• EU vigilance guidelines & their national implementation

• (EUDAMED).• Vigilance during development &

commercialisation.• Risk management process in the quality

management system.• Assessment of benefit/risk balance of

medical devices.

5

12.13 Case Studies• Training of vigilance reporting of

medicines/device combinations.• Training of risk reporting requirements

(risk assessment).

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ADMINISTRATIVE MATTERS ADM

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ADMISSION REQUIREMENTS The selection process is guided by predefined criteria that are publicised at the time of opening the admission applications on the University of Aveiro website.

For applying to the Master or Diploma in Pharmaceutical Medicine, students must have a previous university degree in a health sciences-related field (e.g., medicine, biomedicine, pharmaceutical sciences). Exceptionally and on a case-by-case basis, the Scientific Council of the University of Aveiro can admit applicants who do not have a previous academic degree but whose academic, scientific and professional curriculum reveal an adequate preparation for attending the Programme.

The student can apply for accreditation of prior graduated training or professional experience:

To apply for accreditation of training undertaken as part of graduated training, the student must present appropriate evidence supporting equivalence in learning outcomes (degree certificate, syllabus, programme contents and certificate of marks obtained).

To apply for accreditation of professional experience and other training, the student must present appropriate evidence through Curriculum Vitae and a portfolio, which shall contain, in an objective and unbiased way, relevant information for the purposes of accreditation such as: description of accumulated experience (when, where and in what context, etc.); statement(s) by employer(s) attesting experience; signed certificates of all training obtained; list of learning outcomes, declared by him/herself or by another

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entity (what the student learned from the experience-knowledge, skills and abilities acquired); documents, projects, published articles and other elements that show or reveal the actual acquisition of learning outcomes. Students are advised to discuss this request informally with the Programme staff in the first instance to ascertain whether the experience will be considered appropriate.

Detailed guidance for application for accreditation of prior graduated training and recognition of professional experience are described under the procedure “Pcd. 1-sGA” of the University of Aveiro. For further information, contact the Programme administration. n

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TEACHING METHODSEach module of the “Training Programme in Pharmaceutical Medicine” occurs in a blended learning format (b-learning), a system where a significant part of the students work occurs at distance through the programme e-learning platform, but which necessarily includes situations of classroom teaching and learning (face-to-face courses). The following teaching methods are employed:

Distance learning

This type of teaching method dismisses a permanent physical presence of the student in the formal setting of teaching. The transmission of educational content is accomplished through the Programme e-learning platform. In every module the face-to-face course is preceded by carefully selected pre-course work. Participants receive these materials approximately three weeks in advance before the face-to-face session. The pre-course work is designed to help the students prepare for the modules, foster interaction between the students and the Lecturers, and enhance the effectiveness of the module’s presentations. These may include reading selected articles, reviews, research papers and even web-based exercises. To fulfil this requisite, Lecturers are asked to provide their recommended reading material and lecture notes before the face-to-face course.

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Face-to-face Courses

Courses consist of presentation of lectures, discussion of case studies.

Lectures are delivered by a group of Lecturers who are experts in the scientific domains of their lectures. A balance is achieved between introductory material and up-to-date and expert-orientated material. Whenever possible, digital handouts of presentations are made available in the e-learning platform before the face-to-face sessions. Lecturers are encouraged to use new interactive tools such as “student response technology” that allows lecturers to engage the audience by asking simple questions that have real-time response by the audience by anonymous wireless technologies (e.g. TurningPoint 5) allowing lectures to perform formative assessment and monitoring lecture progression.

When appropriate, case studies may be included during the face-to-face sessions, so that students can challenge their knowledge. In this context Lecturers are encouraged to give tutorial support to the students. n

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CURRICULAR UNIT ASSESSMENTAt the end of each curricular unit, participants are evaluated on their knowledge by a series of written assignments and a multiple-choice exam. These are worth 50% and 35% of the final grade respectively, and are an essential requirement to successfully complete a curricular unit. The remaining 15% correspond to the participation in the face-to-face course.

Assignments

Written assignments usually take the form of research essays, given at the end of a course. An estimate of 100 hours of distance learning should be dedicated to this task. However, each student is encouraged to adjust this estimate according to his or her personal needs, skills and previous knowledge.

A recommended word count upper limit is provided for every written assignment. In each module, the final submission date occurs by default eight weeks after publication in the e-learning platform. Students should submit the exercises in the e-learning platform. If a student considers that he/she will not be able to respect the time limit for delivering the written assignments, either for professional or personal reasons, he/she should inform the Programme Directors as soon as possible, so that an extension period can be negotiated.

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Multiple-Choice Exam

A multiple-choice exam is performed at the end of each module. This exam is answered on the e-learning platform, in presence of the University staff, and by default has the following characteristics:

• Duration: 60 minutes.• The student must log into the e-learning platform with his/

her personal credentials.• Types of questions: Multiple-choice questions and/or “true”

or “false” sentences.• Wrong answers have penalty.• The questions that appear to a given participant are

randomly selected by the computer system from a pool of questions.

• The questions randomly selected are stratified in order to adequately assess the knowledge in all topics belonging to that module.

Pass mark

All assessment activities are marked between 0 and 100%. The pass mark for each module is an aggregate of 50% for all the assessment activities (written assignments, multiple choice exam and participation). Students who fail to achieve the aggregate mark of 50% (i.e. 10 points on the 0-20 point scale used in Portugal) have the following possibilities:• Re-submission of the failed assessments in the second

evaluation period that happens in the same scholar year, according to the university evaluation calendar.

• Re-attempt the failed assessments in the next scholar year. n

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MASTER THESISThe work leading to the Master degree can be a scientific dissertation, a project, or an on-the-job internship of professional nature subject to a final report. The type of thesis work is chosen in accordance to the specific objectives targeted for the student.

Dissertation

The dissertation is based on the performance of an original work of scientific nature, on a pharmaceutical medicine subject. The work must involve the adoption of appropriate methodologies and include theoretical and/or experimental components. The dissertation should reflect a deep domain of the theme as well as the originality of the contribution.

Project

Project work aims the integrated application of knowledge to situations of practical interest and should involve the adoption of appropriate methodologies to solve a specific problem within the pharmaceutical medicine field. Project work may partly occur in the context of a company/organisation and may involve experimental components. The final report should put in evidence the relevance of the activities developed, the state of the art of the area of knowledge involved, and a critical analysis of the results obtained.

Curricular on-the-job internship report

The curricular internship aims to complement the academic training through supervised integration in companies or organizations that provide work environment relevant to pharmaceutical medicine. The internship is based on a plan

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with predefined objectives, programme and schedule, should take place in full time (cantered on the place or places of internship), and involve co-supervision by a University of Aveiro professor and an external expert. The report should demonstrate a thorough knowledge of the activity in which the student worked and the ability to present and critically analyse procedures and/or processes lived in the internship.

Theme proposal

The candidate may submit to the Master’s Director for approval a proposal for the thesis (title and abstract of at least 500 words) that should result from the discussion with the supervisor (and co-supervisor, if applicable). If the candidate will not submit a proposal in a timely way, the Master’s Director will define the thesis subject at his discretion. Future amendments of the title and thesis structure are possible, but the Master’s Director should approve any significant change.

Thesis format

Master thesis should be preferably written in English and must comply with the following macrostructure: title, Board of Examiners, abstract (in Portuguese and English), table of contents, text body and bibliography. The length of the document should be between 15,000 and 20,000 words. Different structures can be applied to the text body structure for a dissertation, a project or a curricular internship report. The templates and page layout approved by the University and available on its website should be used.

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Thesis submission

Each scholar year has two periods for Master thesis public discussion. The normal period occurs in June/July and a special period is open in November/December. The candidate must apply for admission to the examination at the beginning of June in order to discuss the thesis in the normal period and until the beginning of November to use the special period.

To start the submission procedure the candidate must provide the following documents: • Application form. • One hard copy of the master thesis; the front cover should

have the following label: provisional edition.• A declaration form signed by the thesis supervisor and co-

supervisor approving the submission of the thesis.• Any other document required by the Academic

Management Services.

After admission of thesis to discussion by the Master’s Director and after the Board of Examiners has been appointed by the Rector, the Academic Management Services will request the submission of a number of unbound provisional printed copies of the thesis equal to the number of members of the Board of Examiners.

Thesis public discussion The public discussion of the master thesis has duration up to 60 minutes, which includes the presentation of the work by the student and its public discussion with the Board of Examiners. The Board of Examiners deliberates the assignment of marks to the thesis after deliberation on the approval or disapproval of the candidate. Table 3 describes the grading scale used for marking master thesis.

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Table 3 – Master thesis grading scale

Scale (0-20)

Description

18-20 Excellent – Outstanding performance with minor errors

16-17 Very good – Above the average standard but with some errors

14-15 Good – Generally sound work with a number of notable errors

12-13 Satisfactory – Fair but with significant short comings

10-11 Sufficient – Performance meets the minimum criteria

… Fail – some more work required

The Board of Examiners is proposed by the Master’s Director and appointed by the Rector and is composed of 3-5 elements, which include: • The Master’s Director or his delegate, who chairs.• A PhD or expert in the field of the thesis that should,

whenever possible, be external to the Department.• The supervisor and, when applicable, the co-supervisor.• Eventually other PhDs or experts (including the co-

supervisors from other hosting institutions).

Within two weeks after successful public defence, the candidate must submit:• Two copies of the thesis with the final content, after

incorporating the comments by the Board of Examiners. • Three CD’s (not locked with password) with an electronic

copy of the thesis and the student’s curriculum vitae, both in PDF format.

• Copyright Statement (if applicable). n

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PROGRAMME MANAGEMENT

Board of Directors

• Director: Luis Almeida, MD, PhD (Invited Associate Professor, University of Aveiro)

• Deputy Director: Bruno Gago, PharmD, PhD (Assistant Professor, University of Aveiro)

• Associate Director: Miguel Forte, MD, PhD (Invited Associate Professor, University of Aveiro)

External Monitoring Committee

Members:• Carlos Trabulo, MD (Medical Director, Boehringer

Ingelheim)• Frederico Teixeira, MD, PhD (Jubilated Full Professor,

Faculty of Medicine, University of Coimbra) • Isabel Fonseca Santos, MD (Medical Director, Bayer)• Maria João Queiroz, MD (President, Eurotrials SA) • Miguel Vigeant Gomes, MD (Sr Medical Director, Gilead

Sciences)• Patrício Soares-da-Silva, MD, PhD (Full Professor, Faculty

of Medicine, University of Porto)

This Committee is responsible for providing input on the global policies and strategies related to the relevance of the course for the pharmaceutical medicine practice.

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Master’s Course Commission

The Master’s Course Commission comprises three representatives from the registered students and the Board of Directors.

The students’ representatives (two from the Master in Pharmaceutical Medicine and one from the Diploma in Pharmaceutical Medicine) are elected by the registered students.Students can raise any issue of concern to be discussed in the Commission’s meetings through the student representatives. n

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PROGRAMME EVALUATION

Course quality assurance and quality control

At the University of Aveiro, quality assurance and quality control criteria are based on the following principles:• Trainees are supported to acquire the necessary knowledge

and skills• Course structures encourage exchange and

multidisciplinarity• Facilities, infrastructure, leadership and competences

adequate to deliver the approved curriculum• Equality principles• Teaching methods appropriate to the goals of the course• Transparency regarding potential conflicts of interest.

In this way, specific rules and procedures have been established in order to achieve the aforementioned principles. Some of those rules are internal to the Training Programme in Pharmaceutical Medicine and some are general rules that apply to the whole University.

The “Training Programme in Pharmaceutical Medicine” at the University of Aveiro is submitted to the current university procedures for quality assurance and quality review of the teaching process, at each semester:1) Diagnose Phase: This is the beginning of the monitoring

process of the curricular units. It includes an online survey for students and teaching staff aiming to identify curricular units that contrast from the normal standard either for the positive or the negative. Curricular Units above the standard are classified as “Good Practices”; those below the standard are requested to prepare a Mandatory Improvement Plan.

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2) Improvement Phase: This phase is based on the information resulting from the diagnose phase. Each member of the teaching staff formulates a report.

3) Assurance Phase: The reports are analysed by a specific committee.

4) Supervision: The Pedagogic Council, a superior coordination organism for teaching and learning activities at the University of Aveiro, supervises the implementation of the improvement measures.

Many Lecturers of the Training Programme in Pharmaceutical Medicine do not have a formal affiliation to the University of Aveiro. For this staff the Health Science Department created a specific quality control system. All the participants attending each module are asked to complete an evaluation form giving feedback over several dimensions of each presentation and the global module. These forms are analysed resulting in a report distributed to each Lecturer allowing their self-improvement. This report is used on the continuous curriculum improvement process.

Programme accreditation

The Master in Pharmaceutical Medicine is registered at the Agency for Assessment and Accreditation of Higher Education (A3ES), the accreditation body at the Portuguese Education Ministry. The Course Quality Assurance / Quality Control policy follows the rules of the University of Aveiro, which are aligned with the requirements of A3ES.

Since September 2013, the Training Programme in Pharmaceutical Medicine has been recognised as a PharmaTrain Centre of Excellence. n

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OTHER INFORMATION

Accommodation and transport

Courses occur at the venue of University of Aveiro, in Aveiro, or INFARMED - National Authority of Medicines and Health Products, I.P., in Lisbon. Students should book accommodation nearby the venue where the course occurs. Accommodation booking is the responsibility of each student and its costs are not included in the programme fee. Since students are registered in the University of Aveiro, the Programme assures transportation between Aveiro and other course venues.

Registration on the CPD courses

Courses are open to the community. External candidates must complete an Application Form for each CPD course until one week prior to the respective module, limited to the room capacity.

Fees Fees for the 2013/2014 academic year Students registered at the Master in Pharmaceutical Medicine or at the Diploma in Pharmaceutical, in full-time regimen (60 ECTS/year), will pay an annual fee of €1,037.20. This fee is fixed by the University of Aveiro and it can be paid along with the registration or in five partial payments of €172.00 each and one of €177.20, across the academic year. Students registered in part-time regimen (≤30 ECTS/year)

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will pay a fee proportional to the number of ECTS in which they are registered. Registration fees for CPD vary according to the course.

Fees associated to administrative acts (e.g. issue of certificates, etc.) can be found at http://www.ua.pt/sga/PageText.aspx?id=4643.

Library and computing facilities

Students can enjoy the University of Aveiro Library facilities to work, having the possibility to request books and periodicals for a 2-weeks period. Library also has a computing zone where students freely use computers. All the University Campus in covered by WI-FI under the European EDUROAM network.

Email address and login details

All registered students at the University of Aveiro must use personal credentials (e-mail address and password) to access the computer systems. Those credentials give access to all on-line services of the University, such as the e-mail platform, e-learning platform and the online academic management (PACO), available at http://paco.ua.pt/. n

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ORGANISATION:

Training Programme in Pharmaceutical MedicineA PharmaTrain Centre of ExcellenceDirector: Luis Almeida, MD, PhD ([email protected])Deputy Director: Bruno Gago, PharmD, PhD ([email protected])Associate Director: Miguel Forte, MD, PhD ([email protected])

Health Sciences DepartmentUniversity of Aveiro | 3810-193 Aveiro | PortugalTel. +351 234 370 213 | Fax +351 234 401 597 E-mail: [email protected] www.pharmaceutical-medicine.pt

Documents

CourseManual_2013-2014_v2 (1)