paul s. lalvani director and dean empower health vision for sustainable pv in india lhmc, new delhi,...
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PAUL S. LALVANIDIRECTOR AND DEANEMPOWER HEALTH
VISION FOR SUSTAINABLE PV IN INDIALHMC, NEW DELHI, NOV 27, 2010
Training and Capacity Building in PV:Private and Public Partnerships
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Background on PV
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Sources of risks and prevention3
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Benefit – Risk balance : acceptance and optimization
BENEFIT
RISK
Man
agea
ble
Risk
Man
agea
ble
Risk
Man
agea
ble
Risk
Man
agea
ble
Risk
Unacceptable RiskUnacceptable Risk
Acceptable Acceptable RiskRisk
Low High
High
Low
4
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(S)ADR impact in post-marketing ?
During the
last decade
more than 20
drugs
withdrawn
from the
market
5
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Importance of HR and Capacity Building
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Importance of HR and Capacity Building
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
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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
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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 area of the existing academic departments
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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
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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)
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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
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Pharmacovigilance framework
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Pharmacovigilance framework
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Pharmacovigilance framework
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Pharmacovigilance framework
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The Pharmacovigilance Process Flow
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The Pharmacovigilance Process Flow
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The Pharmacovigilance Process Flow
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The Pharmacovigilance Process Flow
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Advanced
JapanUS FDAEurope
Continuum of PV Capacity
Rudimentary Emerging
BangladeshNepalPakistanIndia
KoreaSingaporeChina
Preventative /Reactivee.g. FDA
Precautionary/Proactiveeg: EMA
Source: Adapted from: Lee Ann Patterson, Tim Josling. Regulating Biotechnology. Paper to 76th WEAI, July 8, 2001
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Organizations requiring PV specialists
Healthcare professionals ( physicians, dentist, pharmacist, nurses, etc)
Pharmaceutical companiesDrug regulatory authoritiesBPOsKPOsCROsADR monitoring centers/ hospitals
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About Empower School of Health
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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
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Dr. N K GangulyFormer-Director General,Indian Council of MedicalResearch
Dr. V K SinghDirectorIIHMR-Delhi
Dr. Ross Alexander Breckenridge
University College London
Dr. Rita KariaCEO and PresidentClini RxCRO
Dr. ChandrashekharPotkarDirector, Medical & RegulatoryAffairs, Pfizer
Mr. Rajiv SharmaMD, Empower
Prof. Paul LalvaniDirector, Empower
The advisory council, a body of distinguished persons from academia and industry, provides
strategic guidance to the programme.
Acad
em
ic
Ad
vis
ory
Cou
ncil
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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.
Worl
d C
lass
Collab
ora
tors
Collaborating partners for content, teaching & certification
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Breckenridge, Prof. Ross AlexanderMBBS, 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. StenChief 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. RicardoAssociate 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
Facu
lty
Inte
rnati
on
al
Lindquist, Prof. MarieMarie 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 RalphFormer 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. BruceInternational 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.
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Prof. Ralph Edward, Former Director UMC
Workshop on Pharmacovigilance
Professor Christian BurriDirector, Swiss Tropical Institute at EMPOWER
Prof. Ricardo Pietrobon and team Duke-NUS at EmpowerWorkshop on Clinical Trials
Protocol
Prof. Marie Lindquist, Director UMCAddressing EMPOWER students at
the Workshop on Pharmacovigilance
Mr. Sten Olsson, UMC Swedenat EMPOWER
Prof. Bruce HugmanConsultant, UMC, Sweden
at EMPOWER
Dr. Paolo MiottiUS NIH, US Embassy, New Delhi
at EMPOWER
International Faculty and Visitors at Empower
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Thank you