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

Background on PV

Sources of risks and prevention3

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

(S)ADR impact in post-marketing ?

During the

last decade

more than 20

drugs

withdrawn

from the

market

5

Importance of HR and Capacity Building

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

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

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

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

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)

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

Pharmacovigilance framework

Pharmacovigilance framework

Pharmacovigilance framework

Pharmacovigilance framework

The Pharmacovigilance Process Flow

The Pharmacovigilance Process Flow

The Pharmacovigilance Process Flow

The Pharmacovigilance Process Flow

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

 Organizations requiring PV specialists 

Healthcare professionals ( physicians, dentist, pharmacist, nurses, etc)

Pharmaceutical companiesDrug regulatory authoritiesBPOsKPOsCROsADR monitoring centers/ hospitals

About Empower School of Health

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

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

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

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.

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

Thank you