Transcript Training and Capacity Building in Pharmacovigilance

Training and Capacity Building in PV:
Private and Public Partnerships
PAUL S. LALVANI
DIRECTOR AND DEAN
EMPOWER HEALTH
VISION FOR SUSTAINABLE PV IN INDIA
LHMC, NEW DELHI, NOV 27, 2010
Background on PV
Sources of risks and prevention
3
Benefit – Risk balance : acceptance and optimization
RISK
High
Unacceptable Risk
Acceptable Risk
Low
4
Low
High
BENEFIT
(S)ADR impact in post-marketing ?
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
ADR
Suspicion
ADR
Reporting
ADR
Transmission
ADR
Analysis
Signal
detection
Signal
strengthening
Sharing of
Findings
Recommend
Policy
Changes
The Pharmacovigilance Process Flow
ADR
Suspicion
ADR
Reporting
ADR
Transmission
Rudimentary / Embryonic PV system
ADR
Analysis
Signal
detection
Signal
strengthening
Sharing of
Findings
Recommend
Policy
Changes
The Pharmacovigilance Process Flow
ADR
Suspicion
ADR
Reporting
ADR
Transmission
Rudimentary / Embryonic PV system
Emerging
ADR
Analysis
Signal
detection
Signal
strengthening
Sharing of
Findings
Recommend
Policy
Changes
The Pharmacovigilance Process Flow
ADR
Suspicion
ADR
Reporting
ADR
Transmission
ADR
Analysis
Signal
detection
Rudimentary / Embryonic PV system
Emerging
Planned / Advanced PV System
Signal
strengthening
Sharing of
Findings
Recommend
Policy
Changes
Continuum of PV Capacity
Rudimentary
Bangladesh
Nepal
Pakistan
India
Preventative /
Reactive
e.g. FDA
Emerging
Korea
Singapore
China
Advanced
Japan
US FDA
Europe
Precautionary/
Proactive
eg: 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 companies
 Drug regulatory authorities
 BPOs
 KPOs
 CROs
 ADR 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
Academic Advisory
Council
Dr. N K Ganguly
Dr. Rita Karia
Mr. Rajiv Sharma
Prof. Paul Lalvani
Former-Director General,
Indian Council of Medical
Research
CEO and President
Clini Rx
CRO
MD, Empower
Director, Empower
Dr. V K Singh
Director
IIHMR-Delhi
Dr. Chandrashekhar
Potkar
Dr. Ross Alexander
Breckenridge
Director, Medical & Regulatory
Affairs, Pfizer
University College London
The advisory council, a body of distinguished persons from academia and industry, provides
strategic guidance to the programme.
World Class
Collaborators
Collaborating partners for content, teaching & certification
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.
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.
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
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
Lindquist, Prof. Marie
Faculty
International
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.
Hugman, Prof. Bruce
International Communication Expert.
Consultant, Uppsala Monitoring Centre
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
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.
International Faculty and Visitors at Empower
Dr. Paolo Miotti
US NIH, US Embassy, New Delhi
at EMPOWER
Professor Christian Burri
Director, Swiss Tropical Institute at EMPOWER
Prof. Marie Lindquist, Director UMC
Addressing EMPOWER students at the
Workshop on Pharmacovigilance
Prof. Bruce Hugman
Consultant, UMC, Sweden
at EMPOWER
Prof. Ralph Edward,
Former Director UMC
Workshop on Pharmacovigilance
Mr. Sten Olsson, UMC Sweden
at EMPOWER
Prof. Ricardo Pietrobon and team
Duke-NUS at Empower
Workshop on Clinical Trials Protocol
Thank you