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09101DIAWEB

MARCH 23-25, 2009INTERNATIONALES CONGRESS CENTRUM

BERLIN, GERMANY

2 1 s t

An n u a

lEUROMEET INGB e r l i n 2 0 0 9

PRELIMINARY PROGRAMME

Valdo ArneraGeneral Manager- Europe,PHT Corporation, Switzerland

Peter BachmannSenior Expert European Affairs,BfArM, Germany

Norbert ClemensHead Clinical Development, CRSMannheim GmbH, Germany

Suzy de CordtGroup Leader, Senior Project Manager,Merck Serono, Switzerland

Nikos DedesCo-chair, Patients' and Consumers'Working Party (PCWP), EMEA;Chairman Board of Directors, EATG,EU

Kerstin FranzénSenior Director Worldwide RegulatoryPolicy and Intelligence, Pfizer AB,Sweden

Andreas GrundGeneral Manager, GCP-Service,Germany

Bert HaenenToxicologist, Organon Schering-Plough,The Netherlands

Robert HemmingsStatistics Unit Manager, MHRA, UKand CHMP

Sabina Hoekstra-van den BoschSenior Advisor, Ministry of Health,Welfare and Sport, The Netherlands

Wills Hughes-WilsonDirector Health Policy Europe,Genzyme, Belgium

Alar IrsDeputy Director, State AgencyMedicine, Estonia

Suzette KoxSenior Director, Scientific Affairs,EGA, Belgium

Jürgen KüblerGlobal Head Integrated Safety andHealth Economics Biostatistics,Novartis Pharma AG, Switzerland

Yann Le CamCEO, EURORDIS, France

Christine Mayer-NicolaiRegulatory Coordination Europe andGlobal Regulatory Intelligence, MerckKGaA, Germany

Carolin MiltenburgerDirector Health Economics andOutcomes, i3 Innovus, Germany

Klaus OlejniczakScientific Director, BfArM, Germany

Monika PietrekMD PhD, MSc, Germany

Gabriele SchwarzHead, GCP Inspection ServicesBfArM, Germany

Dagmar StaráHead of Registration Unit, StateInstitute for Drug Control, SlovakRepublic

Barbara SickmüllerDeputy Director General, GermanPharmaceutical Industry Association,Germany

Linda SurhDirector, CEDD Global RegulatoryAffairs, Neurology andPharmacogenetics, GloxoSmithKline,UK

Peter StokmanSenior Director Clinical DataManagement, Organon Schering-Plough, The Netherlands

Helen Van den DungenClinical Quality Assurance, GlobalHead Country Management,Novartis Pharma Services,The Netherlands

John WiseSenior Director, Informatics, DaiichiSankyo, UK

Michael ZuehlsdorfBiomarker Development GlobalHead, Novartis Pharma AG,Switzerland

Theme Leaders

21st DIA Annual EuroMeeting Programme Committee

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About the DIA EuroMeeting

The Drug Information Association’s Annual EuroMeeting is global in scope, attracting well over 3,000 professionals from over

50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, academic

research centres, regulatory agencies, health ministries, patients organisations and trade associations. This convergence

affords attendees the opportunity to network with professional colleagues from around the world.

The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery,

development, regulation, surveillance or marketing of pharmaceuticals or related products. We are committed to the broad

dissemination of information on the development of new medicines or generics and biosimilars, with continuously improved

professional practice as the goal. The DIA is a financially independent non-profit organisation that funds itself from meeting

and membership fees. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops

and training courses and provide publications at reasonable, competitive costs.

Do you have a question about the EuroMeeting? Contact Dermot Ryan, Senior Event Manager (EuroMeeting)

at DIA Europe: dermot.ryan@diaeurope.org.

Christelle Anquez-TraxlerRegulatory and Scientific AffairsManager, AESGP, Belgium

Christer BackmanEU Coordinator, Senior Expert, MPASweden

Gerd BodeConsultant, Germany

Klaus CichutekHead, Department of MedicalBiotechnology,Paul-Ehrlich-Institute, Germany

Hazel CollieGlobal Head, Project Management,Gruenenthal GmbH, Germany

Rosalind CoulsonPhC, MSc, FR, PharmS, UK

Joseph DeGeorgeVice President Safety Assessment,Merck and Co, UK

Hans-Georg EichlerSenior Medical Officer, EMEA, EU

Ralf EulentropProject Head of Leadership Training,Merck Serono, Switzerland

Christoph GleiterDirector Coordination Centre forClinical Trials, University HospitalTübingen, Germany

Wills Hughes-WilsonDirector, Health Policy Europe,Genzyme, UK

David Iberson-HurstVice President, Technical Strategy,CDISC, UK

Michael JamesHead of CMC Policy andIntelligence, GlaxoSmithKline, UK

Truus Janse-de HoogStaff Member Chair, EuropeanCluster, Chair CMD(h), MedicinesEvaluation Board,The Netherlands

Angelike JoosRegulatory Policy Europe, MerckSharp and Dohme (Europe) Inc.,Belgium

Ingrid KlingmannPresident, Pharmaplex, Belgium

Marisa Papaluca AmatiDeputy Head of Sector, Safety andEfficacy of Medicines, EMEA, EU

Francesco PignattiScientific Administrator, Safety andEfficacy of Medicines, EMEA, EU

Johan PröveGlobal Head, Data Management,Bayer Schering Pharma, Germany

Per SpindlerHead, Director, BioLogue, Universityof Copenhagen, Denmark

Ursula Streicher-SaiedHead of Global R and D Quality,Bayer Health Care, AG, Germany

Fergus SweeneyPrincipal Scientific Administrator,GCP and PharmacovigilanceInspector, EMEA, EU

Joachim VollmarExecutive Consultant, InternationalClinical Development Consultants,USA

Ralph WhiteDirector, PPMLD Ltd, UK

Beat WidlerGlobal Head, Clinical QualityAssurance,F. Hoffman-La Roche Ltd,Switzerland

Matthias WilkenHead of Drug Regulatory AffairsEurope, Association of the GermanPharmaceutical Industry, Germany

Programme Advisors

Welcome from the EuroMeeting 2009 Co-Chairs - Barry Burnstead and Dr. Susanne Keitel

Dear Colleague,

We were delighted to be invited by the DIA to chair the 2009 EuroMeeting and particularly enthused by the location selected, Berlin. Delight turned toapprehension as the responsibilities associated with co-chairing became clear. Nevertheless, our resolve is firm and our determination to build upon the successof 2008 unquestioned. The theme approach was very well received in Barcelona and will be retained in Berlin. Certain refinements around the theme sessionshave been identified that will support the quest to have all disciplines interacting at our event.

Alongside the traditional areas of drug development, regulation and patient safety, our desire is to broaden the appeal of the EuroMeeting by introducingcomplimentary topics. Information technology has established itself in a role that is unquestionable, central to all our activities and this will be reflected as aprominent theme in the programme. The vital importance of appreciating the patient’s perspective on drug information will feature strongly and the connectionbetween the worlds of drugs and medical devices will be strengthened, by once more tackling the challenging subject of combination products.

The key to a successful event is for the organising committee to construct a programme that truly represents our member’s interests. This year’s organisingcommittee has performed impressively and has already demonstrated commitment complimented by high levels of expertise. All of us are eager to listen andlearn about what subjects are receiving your attention today. Feedback is vital to the process and we can amalgamate all this information into what we intendto be an irresistible programme. Tough decisions will confront us along the way as the selection process can be challenging. However, we take the responsibilitybestowed upon us by the DIA seriously and will apply our judgment fairly to ensure that we embrace popular opinion and key interests as comprehensively aspossible.

Our sights are firmly focused on Berlin in March 2009 with the clear target of delivering an event that not only fulfils but actually exceeds your expectations.See you there.

Barry Burnstead

Consultant, UKBarry Burnstead has worked in the pharmaceutical industry for 35 years. Formative years were spent in chemistry, project managementand biometrics at SmithKline Beecham. He entered the CRO world in 1991, and a year later with colleagues founded a CRO inGermany and established CRUs in Sweden and the UK. In 1999, he decided to concentrate on consulting and joined Domain Pharma.When Phase Forward acquired Domain, he became global Head of Programme Management. Barry joined i3 Statprobe in August2006 as Director of Project Management and after one year moved to a central role in leading standards implementation. Since May2008, Barry has been working as an independent consultant.

Dr. Susanne Keitel

Director, European Directorate of the Quality of Medicines and Healthcare (EDQM), EUDr. Susanne Keitel joined BfArM in 1997 after 10 years in pharmaceutical development in industry. In the following 10 years withBfArM, she held, amongst others, the positions of Head of Pharmaceutical Quality and Head of EU, International Affairs. She has beena member of various EU working parties, including QWP, PEG, NtA, and, on an international level, ICH Expert Groups. Since October2007, Susanne is Director of the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM).

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Theme 1 Audits and Inspections

Gabriele Schwarz, Head, GCP Inspection Services BfArM, GermanyHelen Van den Dungen, Clinical Quality Assurance, Global Head Country Management, Novartis Pharma Services, The Netherlands

Theme 2 Regulatory Challenges and Controversies - Balancing Access with Safety and Affordability Aspects

Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, Pfizer AB, SwedenDagmar Stará, Head of Registration Unit, State Institute for Drug Control, Slovak Republic

Theme 3 Clinical Research – Increased Complexity by Integration of Real Life Settings

Norbert Clemens, Head Clinical Development, CRS Mannheim GmbH, GermanyAlar Irs, Deputy Director, State Agency Medicine, Estonia

Theme 4 Safety throughout the Product Life-Cycle: Strategies to Better Protect Public Health

Monika Pietrek, MD PhD, MSc, Germany

Theme 5 Knowledge Management

John Wise, Senior Director, Informatics, Daiichi Sankyo, UK

Theme 6 Medical Device Drug Combination: The Medical Opportunities and Regulatory Challenges of the 21st Century

Andreas Grund, General Manager, GCP-Service, GermanySabina Hoekstra-van den Bosch, Senior Advisor, Ministry of Health, Welfare and Sport, The Netherlands

Theme 7Project Management in a Changing Environment

Suzy de Cordt, Group Leader, Senior Project Manager, Merck Serono, Switzerland

Theme 8 Media, Society and Research

Nikos Dedes, Co-chair, Patients' and Consumers' Working Party (PCWP), EMEA; Chairman Board of Directors, EATG, EUYann Le Cam, CEO, EURORDIS, France

Theme 9 Future of Drug Development, Manufacturing and Globalisation - Important Trends and Hot Topics

Barbara Sickmüller, Deputy Director General, German Pharmaceutical Industry Association, GermanyChristine Mayer-Nicolai, Regulatory Coordination Europe and Global Regulatory Intelligence, Merck KGaA, Germany

Theme 10 Impact of Technology and Standards on Drug Development: Now Better, Safer and Faster?

Peter Stokman, Senior Director Clinical Data Management, Organon Schering-Plough, The NetherlandsValdo Arnera, General Manager Europe, PHT Corporation, Switzerland

Theme 11 Optimising Drug Development through Sound Methodology

Jürgen Kübler, Global Head Integrated Safety and Health Economics Biostatistics, Novartis Pharma AG, SwitzerlandRobert Hemmings, Statistics Unit Manager, MHRA, UK and CHMP

Theme 12 Health Economics and Health Technology Assessments

Supporting Sustainable, Socially Acceptable and Equitable Access to InnovationWills Hughes-Wilson, Director Health Policy Europe, Genzyme, Belgium

Carolin Miltenburger, Director Health Economics and Outcomes, i3 Innovus, Germany

Theme 13 Preclinical-clinical Interface: How to Improve Success in Developing Innovative Medicines

Bert Haenen, Toxicologist, Organon Schering-Plough, The NetherlandsKlaus Olejniczak, Scientific Director, BfArM, Germany

Theme 14Personalised Medicine in Drug Development:

Adding Value with New Tools - Biomarkers, Health Economics and DiagnosticsMichael Zuehlsdorf, Biomarker Development Global Head, Novartis Pharma AG, Switzerland

Linda Surh, Director, CEDD Global Regulatory Affairs, Neurology and Pharmacogenetics, GloxoSmithKline, UK

Theme 15 Regulatory Developments and Availability of Biosimilar, Generic, and Self-Care Medicines

Suzette Kox, Senior Director, Scientific Affairs, EGA, BelgiumPeter Bachmann, Senior Expert European Affairs, BfArM, Germany

European Regulatory ForumBrenton James, Strategic Regulatory Affairs in the European Union, Consultant, UK

Thomas Kühler, Director, Operations, MPA, Sweden

THEMES AND TOPICS FOR 2009

2

2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Confirmed Session Chairs include:

Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager,AESGP, BelgiumPeter Bachmann, Senior Expert European Affairs, BfArM, GermanyGlyn Belcher, Vice President Drug Safety and Risk ManagementInternational, Biogen Idec Ltd., UKMike Branson, Global Statistical Methodology Head, Novartis Pharma AG,SwitzerlandNorbert Clemens, Head Clinical Development, CRS Mannheim GmbH,GermanyRosalin Coulson, PhC, MSc, FR, PharmS, UKAndrzej Czarnecki, Director, Deputy Qualified Person For Pharmacovigilance,Global Product Safety, Eli Lilly and Company Ltd., UKJoseph de George, Vice President, Safety Assessment, Merck and Company,Inc., USASarah Daniels, Manager UK Drug Surveillance, Roche Products Ltd., UKHelen Darracott, Director of Legal and Regulatory Affairs, PAGB, UKNancy Dreyer, Senior Vice President, Chief Scientific Affairs, Outcome, USABernd Eberwein, Managing Director, BAH, GermanyVicki Edwards, Senior Director European Pharmacovigilance, AbbottLaboratories Ltd., UKSandy Eisen, Chief Medical Officer, TEVA Europe, UKChristoph Gleiter, Head, CenTrial GmbH, GermanyWalter Haefeli, Medical Director University Heidelberg, GermanyBert Haenen, Toxicologist, Organon Schering-Plough, The NetherlandsJürgen Kübler, Global Head Integrated Safety and Health EconomicsBiostatistics, Novartis Pharma AG, SwitzerlandCecil Nick, Principal Consultant, Parexel Consulting, UKKlaus Olejniczak, Scientific Director, BfArM, GermanySusana Perez Gutthann, Vice President, Global Head, RTI Health Solutions,SpainMonika Pietrek, MD PhD, MSc, GermanyAndreas Reimann, CEO, Cystic Fibrosis Association, GermanyMike K. Smith, Director Pharmacometrics, Pfizer, UKBeata Stepniewska, Director Regulatory Affairs, EGA, BelgiumHolger Rohde, Manager Medical Affairs, PharmaLex GmbH, GermanyHeike Schön, Managing Director, CSG, GermanyBeatriz Silva-Lima, Professor, Pharmacology, CHMP and SAWP member,SWP Chair, University of Lisbon, INFARMED, PortugalJoachim Vollmar, Executive Consultant, International Clinical DevelopmentConsultants, USARichardus Vonk, Head of Drug Discovery Statistics, Bayer-Schering PharmaAG, Germany

Theme 1Audits and InspectionsGabriele Schwarz, Head, GCP Inspection Services BfArM, GermanyHelen Van den Dungen, Head, GCP Inspection Services, Novartis PharmaServices, The Netherlands

Sponsors of clinical trials as well as their contractual partners are forced toimplement effective quality assurance and quality control arrangements inorder to meet the growing expectations regarding quality of clinical trials andproducts. These arrangements need to cover a wide range of facilities,functions and processes. In the theme “Audit and Inspections”, experienceson specific topics such as audits and inspections of e-CRFS and e-source data,data analysis, pharmacovigilance and quality aspects of Advanced TherapyProducts, will be shared. The presentations will also cover challenges relatedto the delegation of sponsor functions to CROs and other third parties, qualityrisk management tools and issue escalation. As more and more products aredeveloped and marketed in a global setting, ethical and quality standardsneed to be harmonised to enable the effective planning and execution ofclinical trials, audits and inspections. Representatives from EU-, US- and otherThird Country Regulatory Authorities will discuss their international GCPinspection programs, procedures and experiences. Throughout the last years,European Competent Authorities have obtained information more oftenabout serious GCP breaches including falsification and fraud. One session willdiscuss sponsor, investigator and patient responsibilities and how to detect,report and avoid those cases.

International GCP Inspection Experiences (Reps from European/ChineseAuthorities and Industry)

Audits and Inspections on Pharmacovigilance in Clinical Trials

Audits and Inspections on E-CRF’s and E-Source Data

Delegations of Sponsor Functions to CROs and other Third Parties

Serious GCP Breaches Including Falsification and Fraud

Quality Risk Management and Risk Detection

Audits and Inspections of Quality Aspects of Advanced Therapy Products

Audits and Inspections of Data Analysis

Summary of the ‘Roundtable/Workshop on GCP Inspection and AuditFindings

Theme 2 Regulatory Challenges and Controversies - Balancing Access withSafety and Affordability AspectsKerstin Franzén, Senior Director Worldwide Regulatory Policy andIntelligence, Pfizer AB, SwedenDagmar Stará, Head of Registration Unit, State Institute for Drug Control,Slovak Republic

Efforts are made today to bring new treatments to the market in a timelymanner especially in areas where there are no or insufficient treatmentsavailable. At the same time, safety awareness is key and an increasinglygrowing notion. Another factor to consider is the affordability of medicaltreatments. The early access to new treatments must be sensibly balancedwith safety considerations and affordability aspects in order to safeguardpublic health. This is the vision for the theme as these aspects have importantimplications for the regulatory environment and impact the regulatoryprocess. The sessions of the theme will discuss different factors playing intothis equation, such as new pharmacometric approaches and the relatedregulatory dialogue, the benefit – risk aspects and how to communicate thisin a way that can be understood by the lay people, cost aspects, and highlightthe regulatory challenges connected with this.

Balancing Access with Safety and Affordability Aspects

Involving Regulators in Novel Drug Development

Novel Pharmacometric Approaches

Benefit - Risk

Enabling Early Access

Health Technology Assessment and Patient and Payer Influence on theRegulatory Process

Communicating Benefit - Risk to the Public

Regulatory Consequences of Outsourcing Clinical Development andManufacturing to India, China

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2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Theme 3 Clinical Research – Increased Complexity by Integration of Real LifeSettingsNorbert Clemens, Head Clinical Development, CRS Mannheim GmbH,GermanyAlar Irs, Deputy Director, State Agency Medicine, Estonia

Everybody has to focus on relevant patient data today, as these are the drivingforces for licensing, treatment and reimbursement decisions. Randomisedclinical trials of good quality represent the most scientifically valid study designfor evaluating the safety and efficacy of new medical treatments. However,for patient relevant data, the usual pivotal clinical trial in its current form maynot always represent the most appropriate tool for generating information onthe safety and cost-related issues of medical treatments. Recently a patientgroup started an open and non-blinded, patient-driven trial, an approach thathas amazing potential but increased risks. Another hot topic is first-in-manstudies with biologicals post TGN1412. Considerable effort has been put intoproviding guidance, which now needs to be transferred into practice. Therequirements for paediatric studies have not completely arrived at theoperational level of clinical development. The sessions of this theme willdiscuss these and other topics of current interest in the clinical field and willprovide up-to-date guidance on future clinical research.

Paediatric Trials

Patient Reported Outcomes

Strategy of Clinical Development

First-in-Man Studies

Patient Recruitment

Novel Approaches in Clinical Research

Multinational Trials in China, Africa and South America

Infectious Diseases

Theme 4 Safety throughout the Product Lifecycle: Strategies to Better ProtectPublic HealthMonika Pietrek, MD PhD, MSc, Germany

In December 2007 the European Commission launched a public consultationon a strategy to better protect public health by strengthening andrationalising EU Pharmacovigilance. This is the latest of several regulatoryinitiatives to improve the safety of medicinal products. Both health authoritiesand the pharmaceutical industry have endeavoured to regain the confidenceof the patients as well as the public. The different aspects identified shouldcontribute to safer products: better understanding of disease mechanisms areaimed at the development of personalised medicines, specific riskminimisation activities and increased scrutiny of post authorisationcommitments additionally will support the protection of patients andconsumers. Also the role of consumer reports has been recognised in the EU,which may provide further insight into the effects of medicinal products whenexposed to large populations. While industry and regulators are implementingthe new regulatory requirements, globalisation and exploding costs of drugdevelopment and healthcare are the other major forces requiringpharmaceutical and biotechnology companies to readjust their workingpractices. Off-shore working, outsourcing and new technologies areconsidered to provide adequate solutions to such challenges. However, theimpact of these changes will only be measurable after a number of years ofexperience. Therefore, it is important that the major stakeholders agree oncommon objectives in support of public health. In particular, societies need todetermine which treatments should be provided and how they wish tobalance benefits, risks and costs. Though public health and the availability ofmedicinal products remain a national responsibility, the safety of medicinalproducts is determined globally through e.g. clinical development,manufacturing, marketing and surveillance. The regulators in US and EU haveacknowledged the need for harmonisation and simplification. The progress,however, will depend on the scope of such efforts and the timeframe forimplementation as well as on the involvement of health authorities in otherjurisdictions, the involvement of other stakeholders and ultimately oneffective communication.

Surveillance: Diseases and Pharmacovigilance – How Good Are Our BaselineData?

EU harmonised Pharmacovigilance Requirements versus GlobalPharmacovigilance - Supplement or Contradiction?

Special Requirements for the Safety of Biologicals and Biosimilars

Safety Decision-making – How much Science is Deployed? An Update onMethodology

Performance and Quality Control in Pharmacovigilance and Risk Management– Too Much or Too Little?

Safety Surveillance Plans: Strategies for Monitoring Safety during theDevelopment Lifecycle

Drug Safety Personnel – Which Qualification and How Much Education isNeeded? Where Do Regulators and Industry Find Talent?

Post Authorisation Studies – Commitments and Reality

Theme 5 Knowledge ManagementJohn Wise, Senior Director, Informatics, Daiichi Sankyo, UK

This theme, broad in scope will consider knowledge management (KM) acrossthe Pharma RandD value chain from clinical candidate selection through todossier submission and review. It sets out to provide value for seniormanagement wishing to catch the key strengths and concerns of thediscipline while providing KM practitioners with a state-of-the-art update onthe status of their discipline, its opportunities and future direction.Key topics will be covered, ranging from a review of current standardsappropriate to KM and their near-term evolution, through mandatory anddesirable “electronic” procedures with the EMEA and European NationalCompetent Authorities, including a detailed assessment of the status and useof the eCTD and PIM. The urgent need better to integrate and minephenotypic and genotypic information during drug development will beaddressed. The potential for exploitation of KM to optimise the myriadprocesses supporting product cross-licensing will be examined by industryexperts. The challenge to exploit knowledge throughout the drugdevelopment lifecycle to support the construction of drug risk managementplans - now an essential part of a marketing application – will be covered,leading up to a tour d'horizon of how effective innovation – so sorely neededin today’s hard-pressed biopharmaceutical industry - can be encouraged,initiated and enabled by KM.The theme will culminate in a key-note concluding address challenging theparticipants to consider the validity of the cry “the Chief Information Officeris dead, long live the Chief Knowledge Officer!”

The EU Knowledge Management Landscape

The "Electronic-only" Centralised Procedure

Towards "Electronic-only" Mutual Recognition, Decentralised and Nationalprocedures.

PIM (Product Information Management)

Knowledge Management in Drug Development

Knowledge Management and Product Cross-licensing

Knowledge Management: An Essential Component of Risk Management andPharmacovigilance

Knowledge Management and Innovation.

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2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Theme 6 Medical Device Drug Combination: The Medical Opportunities andRegulatory Challenges of the 21st CenturyAndreas Grund, General Manager, GCP-Service, GermanySabina Hoekstra-van den Bosch, Senior Advisor, Ministry of Health,Welfare and Sport, The Netherlands

The pharmaceutical and the medical devices sectors could be considered astwo separate sectors, which differ in history, culture, organisational structure,legislation and even in language. However, since the traditional boundariesbetween medical devices and drugs are blurring, there is a need forimprovement of the communication between the two sectors. Nowadays, thepharmaceutical and the device worlds meet each other in the combinationproducts of drugs and devices and in the so-called ‘borderline products’. Thistheme will analyse the current similarities and differences between the drugand the device regulatory systems and will focus on possibilities for workingtogether both on operational and regulatory levels, e.g. in clinical research, inadverse event reporting and in market access. This theme will also reflect themost recent developments in device regulation, such as the changes resultingfrom EU-Directive 2007/47 and from more recent initiatives. New andemerging technologies will have a huge impact on product development inboth the pharmaceutical and the device sector and will result in many newproducts, some of which will be difficult to characterise as either apharmaceutical or a medical device. Also new and emerging technologiescould result in a ‘therapeutic shift’ from drugs to devices and vice versa. Thistheme will highlight some interesting developments in implants andinhalation therapy. This theme will proactively consider what efforts need tobe made to harmonise the sectors and how the future regulation ofpharmaceuticals and of devices could be developed in order to offer the ‘bestof both worlds’ to both pharmaceuticals and medical devices.

New and Updated Regulations: How Do They Affect Medical Device DrugCombinations?

How to Develop/Change SOPs for Drug Device Combinations: What ImpactDoes Device Development Have on a Pharmaceutical Company

Quality Assurance Systems for Drug Device Combination Manufacturers:Experiences of QA Manager and Auditors

Inspection Findings on Investigational Sites and at the Sponsor of Drug DeviceCombination Trials

Drug and Device Safety: How to Combine Reporting Requirements

Expanding our Horizons to Deliver Device and Drug Combination ProductsSuccessfully to Market

New Developments in Drug Delivery Implants: How much Do They Benefit theCurrent Cancer Therapy?

Diagnosis-treatment Combinations (Theranostics) and New InhalationTechnologies

Parallels between Pharma 'Quality by design' (ICH 8-9-10) and DeviceRelevant GHTF Documents

Roundtable: The Spirit of One Team Created from Two Worlds – the Key toSuccessful Development of Devices/Drug Combination Products.

Theme 7 Project Management in a Changing EnvironmentSuzy de Cordt, Group Leader, Senior Project Manager, Merck Serono,Switzerland

Driving drug development projects forward is at the heart of apharma/biotech company, and it is a challenge in a world where the onlyconstant is change. Project Management (PM) is a key success factor. The keyis to rigorously plan and monitor timelines and budget and coordinate thewide cross-functional scope of expertise, whilst staying lean, fast, agile andstrategically focused. This theme will offer a forum to exchange views on howProject Managers and PM tools and processes can help to successfully deliverprojects on time and budget and meeting quality standards, and how tocapitalise on knowledge generated in projects.

Project Manager - Leader or Coordinator?

Project Management Tools - A Help or Hindrance?

Using Project Management to Improve Quality

How to Capitalise on Knowledge-generated Products

Theme 8 Media, Society and Research Nikos Dedes, Co-Chair, Patients' and Consumers' Working Party (PCWP),EMEA, EUYann Le Cam, CEO, EURORDIS, France

Theme summary unavailable at time of going to press

Enhancing Public Trust in Drug Research

Sensational Media Coverage - Risk communication / Risk Management /Science Communication

Transparency for Research Outcomes, Competitiveness and Trust

Between "Pull" and "Push" Information: Where Do Patients really Stand?Direct to Consumer Information. Information to Patients Policy Debates.

Real Life Experience on Patient Involvement on Patient Information?

Society, Patients and Advanced Therapies

Future of EU Pharmaceutical Legislation and EU Pharmaceutical Market: AnOpportunity to Present our Respective Views

Innovative Public Policy to Improve Access to New Medicines

Theme 9 Future of Drug Development, Manufacturing and Globalisation –Important Trends and Hot TopicsBarbara Sickmüller, Deputy Director General, German PharmaceuticalIndustry Association, GermanyChristine Mayer-Nicolai, Regulatory Coordination Europe and GlobalRegulatory Intelligence, Merck KGaA, Germany

Theme summary unavailable at time of going to press

Therapeutic Vaccines

Implementation of ICH Q8, Q9, Q10

Added Therapeutic Value

Further Development of EDQM

OTC Medicinal Products

Innovative Technologies

Advanced Therapies

Drug Counterfeiting

Developments in ICH

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2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Theme 10 Impact of Technology and Standards on Drug Development: NowBetter, Safer and Faster?Peter Stokman, Senior Director Clinical Data Management, OrganonSchering-Plough, The NetherlandsValdo Arnera, General Manager Europe, PHT Corporation, Switzerland

Over the last few years, electronic data capture ( eCRF, ePRO, IVRS/IWRS, etc.)rapidly and dramatically changed clinical drug development. At the currentspeed of EDC adoption, by the end of this decade the paper trial may havebecome extinct. However, neither the ‘loose ends’ in EDC nor the interfacingof the many systems involved make for an optimal process yet, which impedesthe leap from ‘using EDC’ to true eClinical. Rigorous standardisation is one ofthe answers. The various CDISC models offer an end-to-end solution in whichthe use of standards can bring an unprecedented streamlining of data flows,encompassing the healthcare community, investigational sites, pharmacompanies and regulators. Although most companies are able to provideregulators with data in SDTM format, the tremendous improvements thevarious CDISC models can bring remain largely untapped. Both EDC andCDISC are causing a paradigm shift regarding efficiency and quality in clinicaldevelopment. This theme will give us a sense of where we are, and a visionof where we are headed.

Regulatory Acceptance of eSource. Challenging the Regulatory Requirements.Practical Examples. The New EMEA Guidance in Application

Ins-and-Outs of Integration: Needs and benefits of integrating differenteClinical data streams e.g. ePRO, lab, ECG, EDC, end user considerations andexamples

Technology and Standards…How about the Process?

The Loose Ends in EDC and How to Address Them

A Look into the Future: What Is on the Horizon after We Managed EDCProperly?

Using Electronic Health Records in Clinical Development: Theory and Practice

Experience with CDISC Models

CDISC End-to-end: To What Extent?

CDISC as an Avenue to Process Improvement

Theme 11 Optimising Drug Development through Sound MethodologyJürgen Kübler, Global Head Integrated Safety and Health EconomicsBiostatistics, Novartis Pharma AG, SwitzerlandRobert Hemmings, Statistics Unit Manager, MHRA, UK and CHMP

The current RandD process is facing significant challenges: there is a need todevelop efficacious and acceptably safe drugs more efficiently, and to improvein the early identification of drugs that will ultimately fail to prove afavourable profile of benefits and risks. Sound quantitative methods can playa major role in optimising drug development in terms of both design andconduct of an individual study, and design and decision-making across adevelopment programme. The theme will explore statistical approaches toimprove the efficiency with which medicines are developed. This includes athorough discussion of how to optimise implementation of established andnew methodology and their applicability in a highly regulated environment.The theme aims to provide a forum for discussion between industry, academicand regulatory thought-leaders. Relevant experience will be shared anddiscussed, reflecting on lessons learned. By investigating the underlyingprocesses, recommendations for best practice will be developed.

Adaptive Designs I (Introductory/Impletation/Experience)

Adaptive Designs II (Implementation/Experience)

Safety Planning, Evaluation and Reporting

Signal Detection (Statistics)

New Statistical Approaches in Preclinical

Dose Finding

Clinical Scenario Assessment

Regulatory

Theme 12 Health Economics and Health Technology Assessments – SupportingSustainable, Socially Acceptable and Equitable Access to InnovationWills Hughes-Wilson, Director Health Policy Europe, Genzyme, BelgiumCarolin Miltenburger, Director Health Economics and Outcomes, i3Innovus, Germany

Growing budget constraints in healthcare worldwide increasingly determinemarket access and new medical technologies. Evidence of product value iscritical to meet the requirements of reimbursement agencies, clinical guidelinecommittees but also the expectations of patients and physicians. Productvalue goals are therefore essential development objectives, equal inimportance to safety, efficacy and quality. ten years after the introduction ofNICE into the European landscape almost all EU countries have establishedprocesses and standards for HTA and economic appraisal. The theme willexplore the European health policy environment and the variousmethodologies used to build a product value platform as part of drugdevelopment. The theme aims to cover different phases of the productlifecycle, different perspectives and novel approaches. The theme aims to bea forum to exchange and discuss experience and to participate in the searchfor best practice.

Health Economics and Health Technology Assessment in 2009 – A MoreDiverse or More Uniform Landscape?

Access to Innovation: A Role for New Approaches?

Market Access in Europe: How Does Innovation Get to the Patients?

Demonstrating Cost-effectiveness in Challenging Situations and when Data isLimited

Conditional Marketing Authorisations – Managing Health TechnologyAssessments in a Conditional environment

Building HTA into Product Development for Success

Medicines are about More than Money. Building Social Values into HealthEconomics

Clinical Trials: The Start not the End. Building Integrated Data Sets in aEuropean Context to Meet the Needs

What Does the User Consider Value? Including the Patients’ Voice inAssessments

Theme 13 Pre-Clinical-clinical Interface: How to Improve Success in DevelopingInnovative MedicinesBert Haenen, Toxicologist, Organon Schering-Plough, The NetherlandsKlaus Olejniczak, Scientific Director, BfArM, Germany

Preclinical studies are generally used to explore initial safety, pharmacologyand pharmacokinetic behavior of new medicinal products before enteringclinical studies. Even after reaching the clinical stage of development ,preclinical testing continues. In pre-clinical RandD, researchers arecontinuously searching for new techniques, targets, safety endpoints, animalmodels etc. to improve the predictivity of animal studies for the clinicalsituation. One session focuses on juvenile animal studies for first in childrentrials; a session chaired by Beatriz Silva Lima, chairperson of EMEA-SWP.Another session focuses on the safety and efficacy of the new emerging areaof RNAi therapeutics.

Use of Imaging in Non-clinical Toxicity Testing: What Is its Value? What aboutRegulatory Acceptance?

Non-clinical Evaluation of Hepatotoxicity: Where do We Stand? How Skepticis Pharmaceutical Industry?

RNAi Therapeutics Safety and Nonclinical Efficacy Testing and Development

First-in-Man Studies

Update on ICH S6 Guideline: Reprotox of Homologue Monoclonals. Is itUseful?

Update on ICH S6 Guideline: Safety Pharmacology and Long-term Tox Testing

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2009 THEMES - ADDITIONAL SESSIONS - TUTORIALS

Update on Anticancer Drug Guideline and Nonclinical Requirements. WhyNecessary?

Genotoxicity: Revision of ICH S2 and/or Impurities Guideline (staged TTCapproach). Why the Need to Revise? What are Current Industries’ Policies withRespect of Impurity Testing?

Juvenile Animal Testing

Theme 14 Personalised Medicine in Drug Development: Adding Value with NewTools - Biomarkers, Health Economics and DiagnosticsMichael Zuehlsdorf, Biomarker Development Global Head, Novartis PharmaAG, SwitzerlandLinda Surh, Director, CEDD Global Regulatory Affairs, Neurology andPharmacogenetics, GloxoSmithKline, UK

Improved understanding of diseases, mechanisms of drug action and humangenome sequencing have raised public expectations for modern targetedmedicines towards a personalised medicine approach. A doctor prescribing amedicine to a patient might say she/he already practices ‘personalisedmedicine’, so this term may be just a ‘buzz’ word for them. A payerreimbursing the patient’s medicine might say that the economic pressureswithin the healthcare system must drive the future pharmaceutical markettowards individualised treatment to improve efficacy, value and safety. Yethow does anyone (whether regulator, industry researcher or medicalpractitioner) convert complex population data gathered over decades for onenew drug into prescriber decisions and actions which tailor treatment for anindividual. This theme covers key new tools in drug development, fromemerging biomarkers to health economics, with a focus on how these may beexpected to meet the demands of the personalised medicine field. In turn,we will show how this creates specific challenges in the project managementof a new drug by following benefit-risk assessments moving through specificregulatory environments such as drug-diagnostic co-development, healtheconomic evaluations and effective integration of biomarkers which needclinical validation.

Personalised Medicine: Beyond the Buzzword

From Populations to Individuals: Industry Tools and Assessment of Benefit/RiskBalance

Personalised Medicine: A Challenge for Drug Development?

Regulatory Guidelines Compared to Medical Practice Guidelines: Their Placesin Personalised Medicine

Theme 15 Regulatory Developments and Availability of Biosimilar, Generic, andSelf-Care MedicinesSuzette Kox, Senior Director, Scientific Affairs, EGA, BelgiumPeter Bachmann, Senior Expert European Affairs, BfArM, Germany

The regulatory environment is constantly evolving, bringing newopportunities but also new challenges which enhance the need for ongoingdialogue and adaptation by the regulatory authorities and industry.The sessions under this theme will discuss how industry and regulators canmeet these various new challenges and improve the efficiency of the currentregulatory system in order to increase the availability of biosimilar, generic andself-care medicines for the benefit of the patients. The individual sessions willparticularly discuss the current initiatives to optimise the use of resources atthe level of the national competent authorities and the pharmaceuticalindustry, the issues surrounding the introduction of biosimilar products intohigh prescribing areas, the feasibility of a global development program forbiosimilar medicines, the scientific and regulatory perspective regardingsecond generation biosimilar products and patent linkage in the EU regulatorysystems. The sessions on self-care will reflect on how access to non-prescription medicines, whether of chemical or herbal origin, may beimproved by a better regulatory system taking into account the characteristicsof these medicines.

Ways to Improve the Current Regulatory System for Assessment of MedicinalProducts with Known Active Substances

Known Active Substances and Bibliographic Applications - Actual Problems,Possibilities and Solutions

Introduction of Biosimilar Medicines into Clinical Practice

The Path towards a Global Biosimilar Program

Patents and the EU Regulatory Systems

“Smart Regulation” for Non-Prescription Medicines

News on Rx to OTC Switch

Improved Market Access to Herbal Medicinal Products

Additional Sessions

In addition to the sessions contained in the 15 themes, there are many moresessions in development to complete the programme:

• Hot Topics• Stand-alone sessions such as the Japanese Regulatory session and theGerman Satellite session

• European Regulatory Forum sessions

Tutorials

This is a preliminary selection. Additional tutorials to be confirmed ata later date.

1. Detailed Description of Pharmacovigilance Systems for MedicinalProducts for Human Use: Vol. 9A and EU Regulatory Requirements

2. Paediatric Development and Innovative Aspects of Paediatric Trials

3. Risk Management: Turn Plans into Practice

4. The PSUR: A Pharmacovigilance and Medical Writing View withEmphasis on Practical Solutions to the Pitfalls and Grey Areas

5. Analysis of Safety Data from Clinical Trials

6. How to Deal with CP and MRP in an Enlarged EU

7. Interactions Between the Regulatory Regime and the LegalPrinciples Governing Intellectual Property, Competition andProduct Liability for Non-lawyers

8. Qualified Person for Pharmacovigilance: What Do You Need toKnow?

9. Health Economics and HTA – How to Demonstrate Product Value

10. Device Legislation for Pharmaceutical Oriented People

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BE A POSTER PRESENTER

Call for Student Poster Abstracts:Deadline November 21, 2008Full-time university students, residents and fellows are invited to submit abstracts for the Student Poster Session which will take place on Tuesday, March

24, 2009 at the EuroMeeting in Berlin.

A total of EUR 1,800 in prize money will be awarded to student winners based on the following criteria:

• Bona fide research project

• Specific objectives and hypothesis

• Clear methods

• Analysis of actual data and results

• Conclusion

A maximum of 20 abstracts will be selected for the student poster presentation.

Eligibility:

Full-time students, residents or fellows at the time of the presentation. One author or the author’s designee must attend the EuroMeeting.

Benefits:

• One fully supported registration for the EuroMeeting to include: return flight to Berlin, three nights hotel accommodation and complimentary

registration for the EuroMeeting

• A second complimentary EuroMeeting registration for an accompanying person

• Accepted abstracts will be printed in an early 2009 issue of the Drug Information Journal

• A total of EUR 1,800 in prize money

Abstracts:

• All poster abstracts must be received by Friday, November 21, 2008. Submit your abstract online by going to www.diahome.org and clicking on

the EuroMeeting icon.

• Abstracts are limited to 100 words

• A student may submit only one abstract

• Abstracts may not refer to specific brand names

• Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions

• Submissions must include complete contact information

• Abstracts will be reviewed and authors notified of results by Friday, December 12, 2008

Call for Professional Poster Abstracts:Deadline November 21, 2008A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentations to be held on Tuesday, March 24, 2009.

Selected professional poster presenters will be required to pay the applicable meeting registration fee and will be responsible for all other meeting expenses.

Abstracts:

• All poster abstracts must be received by Friday, November 21, 2008. Submit your abstract online by going to www.diahome.org and clicking on

the EuroMeeting icon.

• Abstracts are limited to 100 words

• Abstracts may not refer to specific brand names

• Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions

• Submissions must include complete contact information

• Abstracts will be reviewed and authors notified of results by Friday, December 12, 2008

If you require further information about Student or Professional Posters, please contact Sandra Weberat DIA Europe: sandra.weber@diaeurope.org

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WHAT PAST EUROMEETING DELEGATES HAD TO SAY

“Very insightful; very experienced speakers”

“Detailed discussion of a broad and complex andchanging area, by people directly controlling

them or involved with them”

“Good session; excellent chair”

“Very good presentations – highly informative”

EuroMeeting 2008 Attendees by Country/Region

"The meeting featured the most senior speakers from the various regulatory agencies of any congress I have been to"

"A very good proportion of decision makers on theexhibition floor makes EuroMeeting essential

for our company"

"Excellent networking and very well organised... good opportunities to ask questions after the sessions,

speakers very approachable at DIA"

"Very practical, well balanced between authority,industry and patient view"

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Showcase your company's products and services to more than 3,000 key decision makers - all in the one place, atthe one time! Senior-level professionals at the EuroMeeting in Barcelona included:

1st Secretary Trade and InvestmentActing Deputy Head of Sector, Scientific Advice and Orphan DrugsAdvertising and Medical Information SpecialistAssistant Director - ePROAssistant Vice President Biologics and BiotechAssociate Professor, Pharmaceutical SciencesBiomarker and Experimental Medicine Clinical ScientistBusiness Development and Regulatory Affairs DirectorBusiness Unit Director, Patient Management ProgrammesCardiovascular Portfolio Leader, European Regulatory AffairsChair in Intellectual Property LawChairman and CEOChief Clinical Officer and Executive VPChief Development OfficerChief Executive OfficerChief Medical OfficerChief Medical Officer and Senior Vice President Research and DevelopmentChief Scientific OfficerChief StatisticianChief Technical OfficerClinical Affairs - DirectorClinical Director of PharmacyClinical eSolutions SpecialistClinical Professor, Clinical Pharmacology, Department of PediatricsClinical study Support DirectorClinical Trial ManagerCommercial Development Manager, European Regulatory AffairsCOO and Managing DirectorCorporate Affairs ManagerCorporate Compliance Officer, Vice President, Global RA and QACorporate Regulatory Affairs DirectorCorporate Vice President Drug SafetyCorporate Vice President Information and BiometryData Quality ManagerDean of FacultyDepartment Head, Paediatrics and Medical GeneticsDeputy Director, Industrial Relations, Regulatory Policy and IntelligenceDeputy Director, PharmacovigilanceDirector and Head of MicrobiologyDirector Drug Safety and PharmacovigilanceDirector European Regulatory AffairsDirector Genomics, Office of Clinical Pharmacology, CDERDirector Global LabelingDirector Global QA RandD / MPSDirector Global Regulatory AffairsDirector Global Regulatory AffairsDirector Global SafetyDirector Logistics SolutionDirector Market Access, Pricing and ReimbursementDirector Medical and Regulatory AffairsDirector Medical Affairs InternationalDirector Medicine Group, Global Drug Safety and SurveillanceDirector Non-clinical StatisticsDirector of Clinical Quality ManagementDirector of Corporate Strategy, Medical CommunicationsDirector of Drug Marketing AuthorizationDirector of General MedicineDirector of Health Outcomes EuropeDirector of Legal and Regulatory AffairsDirector of PharmacogenomicsDirector of PharmacovigilanceDirector of Postgraduate EducationDirector of Professional ServicesDirector of SalesDirector of StandardsDirector of the Pharmacy DepartmentDirector Oncology and Biotechnology Therapeutic GroupDirector Operational Regulatory AffairsDirector PharmacouigilanceDirector PharmacovigilanceDirector Pharmacy/Analytic and Inhalation ToxicologyDirector Project ManagementDirector QA and Affairs Regulatory QPDirector QA and ComplianceDirector Regulatory and Scientific Affairs Distributor Markets EAMEDirector Regulatory AffairsDirector Regulatory LiaisonDirector Regulatory Policy, Intelligence and Labeling Regulatory AffairsDirector ResearchDirector Safety ManagementDirector Strategic Regulatory Affairs EuropeDirector Submissions ManagementDirector, Advanced Technology SetupDirector, BiometricsDirector, Clinical Compliance and TrainingDirector, Clinical DevelopmentDirector, Clinical OperationsDirector, Clinical ResearchDirector, Deputy Qualified Person for Pharmacovigilance, Global Product SafetyDirector, Development Planning and ManagementDirector, Discovery BiometricsDirector, Division of Vigilance Risk Management of Medicines

Director, Document ManagementDirector, Drug SafetyDirector, eRegulatory Development, Global Regulatory OperationsDirector, European PharmacovigilanceDirector, Global Pharmacovigilance and Labelling, EuropeDirector, Global Regulatory Sciences InformaticsDirector, InformaticsDirector, Pharmacovigilance Quality System and LicensingDirector, Preclinical AffairsDirector, Preclinical SafetyDirector, Pre-Submission Divison, Worldwide Regulatory AffairsDirector, Product ManagementDirector, Public Private PartnershipsExpert Inspector, GCP and PharmacovigilanceExpert Pre-Clinical AdvisorExpert StatisticianExpert, Senior Director Global Pharmacovigilance and EpidemiologyGlobal Clinical Project DirectorGlobal Director of Medical InformationGlobal EDM ManagerGlobal Head Thesaurus ManagementGlobal Head, Cardiovascular Assessment GroupGlobal Head, Clinical Quality AssuranceGlobal Head, Data ManagementGlobal Head, Project ManagementGlobal Manager Clin Ops.Global Medical DirectorGlobal Medical Writing DirectorGlobal Operations Business Development ManagerGlobal Pharmacovigilance and Epidemiology - EuropeGlobal Quality ManagerGlobal Regulatory StrategistGlobal Safety Sr. ManagerHead Clinical OperationsHead Clinical Research and DevelopmentManager Regulatory Affairs Operations EuropeMedical and Regulatory Affairs DirectorMedical Director Australia and New ZealandMedical Director of Clinical ResearchMedical Director, Pharmacovigilance VaccinesPost-Marketing DirectorPresident Pharmaceuticals EuropeProfessor Analytics and ResearchProfessor in Drug SafetyProfessor of Clinical PharmacologyProfessor of Pediatrics and PharmacologyProfessor of Pharmaceutical TechnologyProfessor of Pharmacology/Head of Perinatal and PediatricProfessor, Clinical PharmacologyProfessor, Department of PharmacoepidemiologyRegional Head, Global Medical WritingRegional Medical DirectorSubmission Manager EuropeVice President OncologyVice President RA and QAVice President, Global Regulatory Policy and OperationsVice President, Neurosciences, Global Clinical Safety and PharmacovigilanceVice President, PharmacoepidemiologyVP, Clinical Quality and ComplianceVP, Enterprise SolutionsVP, Global Regulatory Affairs and SafetyVP, Nonclinical Safety Project, Safety AssessmentsVP, Project Management Portfolio and Planning

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Exhibit at the EuroMeeting 2009

Showcase your company's product or service to over 3000drug development professionals at the EuroMeeting 2009 inBerlin.

Join over 240 exhibitors to interact with professionals fromthe pharmaceutical, biotechnology, devices, government,academia, healthcare delivery and related industries, fromover 50 countries.

For further information, please contact Phyllis Suter at DIA Europe: phyllis.suter@diaeurope.org or call +41 61 225 51 54

NETWORKING - ALL INCLUDED IN REGISTRATION FEE

Networking Receptions,Coffee and Lunch BreaksEuroMeeting attendees tell us that the

networking opportunities presented by the

EuroMeeting are one of the key reasons for

attending. Each year, the EuroMeeting offers

numerous opportunities to catch up with

existing contacts and to make new ones in a

relaxing setting. All networking events at the

EuroMeeting are included in the registration fee:

food, beer, wine, non-alcoholic beverages and

entertainment.

Jitterbug ReceptionMonday evening will see DIA rocking and rolling

to a networking banquet reception at the Palais

Am Funkturm. The Palais is one of the largest

and most beautiful ballrooms in Berlin and is a

premiere venue for social functions. Located just

a short walk from the Convention Centre, it is

the perfect choice for Monday’s reception. In a

well-preserved 1950s interior, from the gilded

ceiling to the elegant staircase to the panoramic

bay windows, the Palais Am Funkturm cannot

fail to impress. The theme of the reception will

be the 1950s with music and dance to fit the

theme. The Palais am Funkturm is beside the

famous Berlin Funkturm (Radio Tower)

completed in 1926.

Other Opportunities

• A Regulators Lunch on Monday is an essential part of the programme for

regulators from national agencies and the EMEA.

• On Tuesday, all attendees get together for a drinks reception on the

Exhibition Floor. Entertainment provided.

• DIA’s Special Interest Area Communities (SIACs) offer a discipline-specific

global community where members can share experiences and knowledge,

find common ground, and network with others in their fields. SIAC

activities are an integral part of the EuroMeeting and they will organise at

least one networking opportunity in 2009.

• The EuroMeeting’s Exhibition Floor, with over 250 exhibitors, is a great

place to network. All refreshment breaks take place on the Exhibition

Floor, so it is easy to meet colleagues and friends.

• Patient Representatives are supported each year by DIA to attend the

EuroMeeting where attendees will have a chance to meet them and listen

to their priorities and concerns.

• New to the pharmaceutical industry? The EuroMeeting offers emerging

professionals the chance to meet in a special session.

• Over the past years, DIA Europe has increased the opportunities to attend

the EuroMeeting. There will be a specific networking programme for

students at the 2009 EuroMeeting in Berlin.

JOIN US IN BERLIN

The CityAt the very heart of Europe, Berlin is a bridge between east and west and over the last few years, has

evolved into a major platform for communication and knowledge transfer. Berlin is ranked first among

Germany’s best conference locations and is in the international top five.

Easily accessible, Berlin has three airports providing flight connections to the whole world with 91 airlines

operating flights to Berlin from 157 cities in 49 countries. When in Berlin, one of the most extensive

underground and regional train systems of any major city in the world as well as over 1,000 buses and trams

will help you get around. If that’s not enough, over 7,000 taxi cabs will take you whenever and wherever

you want to go.

Berlin can boast an outstanding selection of hotels, with more than 600 available across all categories,

offering the largest and most modern selection of accommodation in Europe. Nearly all the major international hotel chains are already here.

Berlin is cosmopolitan and open 24 hours a day, 7 days a week. About 1,700 events every day are entertaining people from all over the world. A variety of

restaurants from all different kinds of cultures and countries, as colourful and diverse as the city itself, are on offer. Every district, every street corner offers

something new and exciting. One thing is certain, Berlin is always changing and it is this dynamism that gives Berlin its special appeal.

Comprehensive information on a range of topics, from flying to Berlin to restaurants to beer gardens to sightseeing can be found at the tourist information

website: www.visitBerlin.de

The Convention Centre

The Internationales Congress Centrum Berlin (ICC Berlin) ranks among the biggest, most advanced and most

successful congress venues in the world. It was designed by architects Ralf Schüler and Ursulina Schüler-Witte. The

ICC Berlin is a landmark of postwar German architecture and the model for many new congress centres all over the

world. With its 80 halls and rooms seating between 20 and 9,100, its versatile facilities, superb technical installations

and comprehensive range of services, ICC Berlin is the perfect choice for any convention.

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Special Hotel Rates for your EuroMeeting 2009 Accommodation in Berlin

5-Star HotelsConcorde Berlin 200.00 220.00Kempinski Bristol 190.00 215.00Palace Berlin 195.00 195.00 215.00Steigenberger Berlin 235.00 255.00Intercontinental Berlin 210.00 230.00

237.00 257.00The Westin Grand 268.00 337.00

298.00 367.00

4-Star HotelsCalifornia Hotel 135.00 150.00Crowne Plaza Berlin City Centre 210.00 230.00Ellington Hotel 135.00 162.00Golden Tuilp Hotel Hamburg 150.00 180.00Hecker’s Hotel 146.00 166.00 182.00Hollywood Media Hotel 140.00 150.00 160.00Maritim proArte 211.00 244.00

227.00 260.00Melia Berlin 197.00 219.00NH Berlin Kurfürstendamm 197.00 215.00NH Jolly Berlin Friedrichstrasse 208.00 227.00Novotel Tiefgarten 199.00 232.00Park Inn Berlin 136.00 136.00 163.00Seehof 210.00 250.00

3-Star HotelsArt’hotel Kudamm 130.00 145.00Berlin Plaza Hotel 89.00 109.00 126.00Concorde am Studio 95.00 115.00Ku’damm 101 87.00 105.00 105.00Mark Apart Hotel 110.00 130.00Mark Hotel Berlin 110.00 140.00Sylter Hof 90.00 112.00 134.00

2-Star HotelsIbis Messe 99.50 129.00

Headquarter HotelsHilton Berlin (HQ Central) 228.00 272.00Sofitel Schweizerhof (HQ West) 200.00 220.00

Hotel Name Single Room Double Room Double Roomincl. Breakfast for single use incl. Breakfast

incl. Breakfast

DIA’s accommodation agent in Berlin, KIT, has negotiated special rates exclusively forEuroMeeting 2009 participants. To make a reservation and/or to get more information,

go to www.diahome.org and click on the EuroMeeting icon.

Berlin Tours

Make the most of your stay in Berlin and meet other EuroMeeting participants by reserving a place on one of our city tours. There are four tours to choosefrom: two on Sunday and one on both Tuesday and Wednesday.

Sunday March 22, 2009Morning, Orientation Tour through Berlin’s Architecture, 4 hoursAfternoon, Jewish Life in Berlin, 4.5 hours

Tuesday, March 24, 2009Afternoon, Berlin Panoramic Tour, 3 hours

Wednesday, March 25, 2009Morning, The Government Quarter, 4 hours

For details, go to www.diahome.org and click on the EuroMeeting 2009 icon.

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2009 is a special year to be in Berlin, marking the 20th anniversary of the fall of the Berlin Wall. After "The

Wall" was opened in 1989, hundreds of artists from all over the world gathered and transformed the East Side

Gallery, a 1.3km-long section of the wall near the centre of Berlin in celebration and reflection of this freedom

achieved. Approximately 106 paintings by artists from all over the world cover this memorial for freedom and

make it the largest open air gallery in the world. With the recognition of its special connection of the past and

to the present, an artists initiative was formed to preserve this "gallery" and later won Historical Monument

status. To support the East Side Gallery, please visit: www.eastsidegallery.com

The image chosen for Berlin 2009 on the cover reflects the global, diverse ethos of the DIA itself. It is of a East

Side Gallery mural by artist Kiddy Citny.

Kiddy Citny is a musician and fine artist, born in Stuttgart in 1957. He grew up in Bremen, moved to West

Berlin in 1977, lived in Amsterdam and London (1979), in Zurich (1980), Bern (1989/90), Los Angeles

(1993/94), and also used a studio in Munich until 2000. Citny is a famous Berlin Wall graffiti artist who began

playing cat and mouse with German border guards back in 1985. His work features the themes of love and

mutuality, peace and freedom, sensitivity and tenderness, willpower and responsibility. Kiddy Citny

communicates complex issues with simple metaphors: "Herzgesichter" [heart-shaped faces], "Welt im Arm"

[the world in your arms], "Königskinder" [royal children].

Would you like to receive complimentary admission to the 21st Annual EuroMeeting in Berlin, March 23-25, 2009, featuring approximately 120 sessions,

350 speakers and numerous networking opportunities.

DIA Young Professionals Fellowship: Application Deadline December 1, 2008DIA Europe welcomes the involvement of young professionals in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15

young professionals in full-time employment under the age of 30.

DIA Student Fellowship: Application Deadline December 1, 2008DIA Europe welcomes the involvement of students in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 students in full-

time education.

DIA Patient Fellowship: Application Deadline December 1, 2008The DIA Patient Fellowship, now in its fourth successful year, is a programme to promote the participation of patients organisation representatives in the

EuroMeeting. In 2008 DIA supported 22 patient representatives’ participation in the EuroMeeting by covering their complete travel and accommodation

costs plus complimentary admission to the EuroMeeting in Barcelona and offered 20 additional patients representatives complimentary registration for the

EuroMeeting, thus enabling a total of 42 patient representatives to actively participate in the EuroMeeting.

• Complimentary admission to conference and pre-conference tutorial of choice

• Specific DIA Patient Fellowship Booth to act as a focus point to network and to distribute information

• Travel costs covered

• Up to 3 nights complimentary hotel accommodation provided

• Patient Fellowship Reception on Sunday evening and daily briefings to encourage information and skills sharing

Fellowship Application Process:

Application Packs for all three fellowships can be obtained by contacting Sandra Weber at DIA Europe: sandra.weber@diaeurope.org or by calling +41 61

225 5164 or by going to www.diahome.org and clicking on the EuroMeeting icon.

DIA Fellowships

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