1. PAUL S. LALVANI DIRECTOR AND DEAN EMPOWER HEALTH VISION FOR SUSTAINABLE PV IN INDIA LHMC, NEW DELHI, NOV 27, 2010 Training and Capacity Building in PV: Private and Public Partnerships

2. Background on PV

3. Sources of risks and prevention 3

4. Benefit – Risk balance : acceptance and optimization BENEFIT RISK Manageable Risk Unacceptable Risk Acceptable Risk Low High Low 4

5. (S)ADR impact in post-marketing ? During the last decade more than 20 drugs withdrawn from the market 5

6. Importance of HR and Capacity Building

7. People are the most important asset of any organization 1. RIGHT People 1. RIGHT People in the RIGHT POSITIONS 2. RIGHT People in the RIGHT POSITIONS with the right TRAINING

8. However Demand for PV Specialists > Supply The supply-demand situation for skilled manpower [in pharmacovigilance] is highly skewed in favor of the demand * Why Demand is growing so rapidly:  New regulations on pharmacovigilance in India and many countries  Launch of the PvPI – pan India  Non harmonized regulatory requirements for pharmacovigilance  Enforcement of pharmacovigilance by NDRAs  Threat of penalties for non compliance  Increased awareness of patient safety issues among patient population  Several companies have a large (many drugs) and multi-country portfolio, requiring a complex system of pharmacovigilance management *Training in Post-Authorization Pharmacovigilance

9. However, Supply continues to Lag Several factors limit supply This field is relatively new in India and elsewhere  Manpower with long-term experience and wide exposure to the science of pharmacovigilance limited  Not a well established academic specialization  Very few universities and Institutes offer specialized courses in PV  Spans a wide range of subjects  Pharmacology, epidemiology, clinical medicine, data management, drug legislation &communication  Multi-discipline approach does not easily fit within the competence a rea of the existing academic departments

10. Syllabus Topics Taught by Empower The Need for Pharmacovigilance Drug Related problems in health care Clinical manifestations of ADRs The practice of spontaneous reporting Epidemiological methods (DUR, CEM, etc) Regulatory requirements Literature sources for drug safety Special areas (AEFIs, counterfeit, ethics, etc) Benefit – harm assessment and decision making Communicating drug risks in pharmacovigilance (with HP, patients, regulatory bodies) Risk Management (preventing ADRs) Statistics and softwares in pharmacovigilance Drug safety data management Starting and managing a pharmacovigilance department in a company (pharma/ CRO) Compliance with and inspections of pharmacovigilance

11. Combining Public and Private Sector Leader PV capacity in private sector exceeds public / academic sector PV in private sector is responding to international requirements and has scaled up their capacity Leveraging private sector to building capacity of academic and public sector is valuable In US-EU, private sector works closely with public and academic sectors (while managing conflict of interest)

12. Combining Indian and International Leaders PV in India is less than 10 years old—few people have worked in PV for more than 2-3 years PV in developed countries and WHO /UMC has been conducted for 40 years Leveraging international expertise is important to building Indian capacity UMC/WHO/US FDA / EMA are all providing support in India

13. Pharmacovigilance framewor k

17. The Pharmacovigilance Process Flow ADR Suspicion ADR Reporting ADR Transmis- sion ADR Analysis Signal detection Signal strengthen- ing Sharing of Findings Recommend Policy Changes

18. The Pharmacovigilance Process Flow ADR Suspicion ADR Reporting ADR Transmis- sion ADR Analysis Signal detection Signal strengthen- ing Sharing of Findings Recommend Policy Changes Rudimentary / Embryonic PV system

19. The Pharmacovigilance Process Flow ADR Suspicion ADR Reporting ADR Transmis- sion ADR Analysis Signal detection Signal strengthen- ing Sharing of Findings Recommend Policy Changes Rudimentary / Embryonic PV system Emerging

20. The Pharmacovigilance Process Flow ADR Suspicion ADR Reporting ADR Transmis- sion ADR Analysis Signal detection Signal strengthen- ing Sharing of Findings Recommend Policy Changes Rudimentary / Embryonic PV system Planned / Advanced PV System Emerging

21. Advanced Japan US FDA Europe Continuum of PV Capacity Rudimentary Emerging Bangladesh Nepal Pakistan India Korea Singapore China Preventative / Reactive e.g. FDA Precautionary/ Proactive eg: EMA Source: Adapted from: Lee Ann Patterson, Tim Josling. Regulating Biotechnology. Paper to 76 th WEAI, July 8, 2001

22. O rganizations requiring PV specialists Healthcare professionals ( physicians, dentist, pharmacist, nurses, etc) Pharmaceutical companies Drug regulatory authorities BPOs KPOs CROs ADR monitoring cent ers/ hospitals

23. About Empower School of Health

24. Empower Health and pharmacovigilance education UGC certified PG diploma specialized in pharmacovigilance ; 1 year course UGC certified MSc in CR and pharmacovigilance ; 2 year course More than 50% of our first year batch is joining pharmacovigilance (including conducting international projects in Switzerland) Content and teaching is conducted in collaboration with Uppsala Monitoring Centre and India pharmacovigilance experts (academia and industry) Expanding from Delhi to 4 other cities in India

25. Dr. N K Ganguly Former-Director General, Indian Council of Medical Research Dr. V K Singh Director IIHMR-Delhi Dr. Ross Alexander Breckenridge University College London Dr. Rita Karia CEO and President Clini Rx CRO Dr. Chandrashekhar Potkar Director, Medical & Regulatory Affairs, Pfizer Mr. Rajiv Sharma MD, Empower Prof. Paul Lalvani Director, Empower The advisory council, a body of distinguished persons from academia and industry, provides strategic guidance to the programme. Academic Advisory Council

26. Based in Sweden, Uppsala Monitoring Centre is an independent centre of scientific excellence and is the field name of World Health Organization (WHO) collaborating centre for international drug monitoring. Set up in 1978, eighty two countries currently actively contribute to its database. The 118 year old University College London is ranked seventh by Times Higher Education –QS World University rankings 2008, ahead of MIT, John Hopkins and Stanford. It works across the globe with government, educational institutions, industrial, and professional organizations and has an enviable record of ground breaking research. World Class Collaborators Collaborating partners for content, teaching & certification

27. Breckenridge, Prof. Ross Alexander MBBS, PhD University of Cambridge, Clinical Pharmacology/General Medicine Consultant Physician; Senior Lecturer in Clinical Pharmacology at University College London. Responsible for M Sc program in Drug Development at UCL; Chair, Clinical trials Safety Committee, University College London Research and Drug Development Dodoo, Alexander, Prof. MSc and Ph.D at the Department of Pharmacy, King’s College London. UK Senior Research Fellow and the Acting Director at the Centre for Tropical Clinical Pharmacology & Therapeutics (CTCPT) of the University of Ghana Medical School.. Established the Ghana National Centre for Pharmacovigilance in 2001, the fi rst such centre in West Africa. Olsson, Mr. Sten Chief WHO Programme Officer, WHO International Uppsala Monitoring Center, Sweden. MSc Pharmacy (University of Uppsala, Sweden). Responsible for development of the WHO medicine safety programme and pharmacovigilance around the globe. Carried out pharmacovigilance training in more than 35 countries in 5 continents. Editor of the book ‘National Pharmacovigilance Systems’ (2nd ed 1999) and the newsletter Uppsala Reports Pietrobon, Prof. Ricardo Associate Professor & Vice Chair, Dept. of Surgery, Duke University Medical Centre, USA MS, PhD, Masters in Business Management. Director Research on Research Group, Duke NUS Graduate Medical School, Singapore; Orthopedic Surgeon Faculty International Lindquist, Prof. Marie Marie Lindquist is an M.Sci in pharmacy, Uppsala University, Sweden, and a Doctor in Medicine, the University of Nijmegen, The Netherlands. Currently she is the Director, Uppsala Monitoring Centre, Sweden and has overall responsibility for the development and scientific and professional activities of the Centre, matters relating to the WHO Programme for International Drug Monitoring, and relationships with other organisations. Edwards, Prof. Ivor Ralph Former Director, Uppsala Monitoring Centre, Sweden; Physician; Teacher at undergraduate and graduate levels; As clinical toxicologist in the fi eld of drug abuse, acute and chronic poisoning, toxicity from industrial chemicals and adverse drug reactions; Medical Assessor for Adverse Drug Reactions, Ministry of Health New Zealand Hugman, Prof. Bruce International Communication Expert. Consultant, Uppsala Monitoring Centre Burri, Prof. Christian Head of Department for Pharmaceutical Medicine of the Swiss Tropical Institute. Direction of Unit conducting several projects in the field of drug and vaccine testing executed by the STI. Project Director of the Alliance for Clinical Research & Clinical Epidemiology in the Democratic Republic of Congo (ARCEAU-RDC). Associate professor for pharmacy & clinical pharmacology with research focus on human African trypanosomiasis medication pharmacology.

28. Prof. Ralph Edward, Former Director UMC Workshop on Pharmacovigilance Professor Christian Burri Director, Swiss Tropical Institute at EMPOWER Prof. Ricardo Pietrobon and team Duke-NUS at Empower Workshop on Clinical Trials Protocol Prof. Marie Lindquist, Director UMC Addressing EMPOWER students at the Workshop on Pharmacovigilance Mr. Sten Olsson, UMC Sweden at EMPOWER Prof. Bruce Hugman Consultant, UMC, Sweden at EMPOWER Dr. Paolo Miotti US NIH, US Embassy, New Delhi at EMPOWER International Faculty and Visitors at Empower

29. Thank you