Managua, 26.11 – 28.11

Anton Karasavidi, Vice - Rector,Saint-Petersburg State Chemical Pharmaceutical Academy

of the Ministry of Healthcare of Russia

ФАРМА 2020

Managua, Nikaragua, 26.11-28.11

ФАРМА 2020

Brief history

The idea of foundation of the higher educational institution in the field of pharmacy in Russia belongs to D.I. Mendeleev.

Saint-Petersburg State Chemical And Pharmaceutical Academy was founded in 1919 as Petrograd Pharmaceutical Institute

Today the Saint-Petersburg State Chemical Pharmaceutical Academy is the leading educational center of the RF on training engineers-biotechnologists specialized in the manufacture of pharmaceuticals of different origin.

Joint curricula with the departments of the Pharmaceutical Faculty (pharmacology, biochemistry, pharmacognosy, etc.) enable the students to acquire a unique combination of knowledge inaccessible for the students of polytechnics.

Managua, Nikaragua, 26.11-28.11

ФАРМА 2020

Scientific potential

• Research for the new biologically active substances of synthetic origin (heterocyclic compounds, modified polysaccharides, chelates of d-elements), as well as those obtained biotechnologically or derived from plants and plant tissue cultures

• Pre-clinical studies. Areas of competency: oncology, COPD, neurology, infections (bacterial, fungal, influenza, HSV, helminthes), antiarrythmic drugs, anticoagulants

• Development of the technology of the chemical synthesis and of the finished products manufacture (tablets, injections, infusions, ointments and forms with modified release)

• Quality control studies, preparation of the pharmacopoeial monographs, specifications for the newly developed drugs.

• Toxicologic chemistry analysis

Managua, Nikaragua, 26.11-28.11

ФАРМА 2020

Competitive advantages of the academy

• More than 50-years experience and leadership in the field of training specialists for the pharmaceutical industry of Russia. Contacts with all pharmaceutical organizations of Russian Federation

• Integration and synergy of educational potential of two faculties – pharmaceutical and biotechnological.

• Working system of specialists training and development in the field of biotechnology of drug products of microbiological and animal origin, fine organic synthesis, manufacture of finished products and plant-based preparations.

• Location in Saint-Petersburg that provides the possibility of deep integration in the area of science and education with the other institutions and research organizations, collaboration with the industrial and innovative companies (including base for practical training, implementation of co-projects) in the field of staff training, matching of the purposes of Saint-Petersburg pharmaceutical cluster, realized at the federal and regional levels.

• SPCPA is involved in the project of federal special-purpose programme «The Development of pharmaceutical and medical industry of the Russian Federation for the period up to 2020 and further».

• Active participation in the development of pharmaceutical cluster in Saint-Petersburg.• Interacademic science centre

Managua, Nikaragua, 26.11-28.11

ФАРМА 2020

Participants of Saint-Petersburg Pharmaceutical Cluster

• Saint-Petersburg Chemical-Pharmaceutical Academy• Saint-Petersburg Technological University• Saint-Petersburg Pavlov Medical University• Saint-Petersburg Polytechnic University• Research Institute of extra pure biopreparations• Research Institute of cytology• Research Institute of toxicology• Research Institute of influenza• Manufacturers: Biocad, GeroPharm, Vertex, Samson-Med, Novartis,

Takeda, AstraZeneca, Stada, Berlin-Chemie.

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

National centre for personnel training

Training – BASIC COURSE «Good Manufacturing Practice and Good Distribution Practice of drugs (GMP and GDP)»    

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

National centre for personnel training - 2011

Joint studies in the field of quality management of pharmaceutical manufacturing and industrial aseptics

Academy in FIP - International Pharmaceutical Federation (FIP)

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

More than Education 2012-2014

Practical training of SPCPA students at the finished product manufacturing plant of Pfizer company in Turkey

Practical training of SPCPA students at the biotechnology plant of Pfizer company in Ireland

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

• Joint department of recombinant proteins technology was organized

• Academy is a partner of BIOCAD– Within the framework of affair 1.2 of Federal Targeted Program - «Development of the

technology and manufacture organization of vital and most important synthetic medical drugs currently not manufactured by national producers and protected by patents of foreign companies within the territory of Russian Federation»

– Within the framework of affair 2.5. (Ministry of Education and Science) - «Pre-clinical studies of innovative medical drugs» of Federal Targeted Program «Development of pharmaceutical and medical industry of Russian Federation for the period until 2020 and further prospective»

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

Partnership in the field of scientific, medical, and pharmaceutical personnel training in Saint-Petersburg «Time of new ideas»

Managua, Nikaragua, 26.11-28.11

ФАРМА 2020

Managua, Nikaragua, 26.11-28.11

Biopharmaceutical laboratory for students

PHARMA 2020

Tempus

Managua, Nikaragua, 26.11-28.11

Knowledge Sharing on Drug Development -

the Merck/Yale initiative

Marcelo E. Bigal, M.D., Ph.D.Head of the Merck Investigator Studies Program and Scientific Education Group

Office of the Chief Medical OfficerMerck Inc.

PHARMA 2020

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

Training unit for Good Manufacturing Practice (GMP) and regulatory

relationships in the area of pharmaceutical industry(GMP-Training Centre)

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

Research and Implementation Centre in quality management

representative training in the area of pharmaceutical industry and

medical drugs distribution

FinlandLappeenranta

Managua, Nikaragua, 26.11-28.11

Research of biologically active substances

Development of drug productsmanufacturing technologies

Methods of standardizationand quality control

Elaboration of drug product dossier

Pharmacological screeningand preclinical studies

Organization of drug productsexperimental manufacture

Centre of activesubstances synthesis

Centre of pharmacologicalresearch

Centre of drugsmanufacture development

Centre of quality controland standartization

Centre oftechnologies transfer

Scientific collaboration:Centre of science

and education Centre of innovationsand im

plementation

Managua, Nikaragua, 26.11-28.11

PHARMA 2020

Center of Excellence in SPCPASupercomputer

Vivarium

Synthetic laboratoryModern equipment

Pilot manufacturing

Managua, Nikaragua, 26.11-28.11

Center of Excellence• Laboratory for computer simulation;• Laboratory of synthesis (excretion) of active

pharmaceutical ingredients;• Laboratory for pharmacological studies• Analytical center• Experimental-industrial production• Technological transfer center

APS Dosage forms

Production technology

Surveying activities

In silico In vitro In vivo In situ

Structure

Methods

Products Personnel training

Center of Excellence role in the development of the Russian pharmaceutical industry

• Providing research centers with conventional and SPF-animals

• Conduct scientific researches in accordance with international standards

• Preclinical studies of medical devices on mini pigs• Ability to conduct contracts based scientific research

works

PHARMA 2020

New educational programs in 2014

BionanotechnologyNanostructured DrugsImmunobiotechnology

Industrial System Fermentation Process Validation in Manufacturing of

Biopharmaceuticals

Managua, Nikaragua, 26.11-28.11

Thank you for your attention!www.spcpa.ru Contact persons :

• Anton Karasavidi, Vice - Rector,e-mail: Anton.Karasavidi@pharminnotech.com,