This document discusses establishing pharmacovigilance centers in industry and national pharmacovigilance programs. It outlines the basic steps in setting up a pharmacovigilance center, including making contacts, designing reporting forms, educating staff, establishing a database, and promoting reporting. The document also discusses establishing pharmacovigilance programs in industry and the roles of contract research organizations and India's national pharmacovigilance program organization in monitoring drug safety.

1. Establishing Pharmacovigilance
Centers In Industry And National
Programme Related To
Pharmacovigilance
MOHD MONISH
M PHARM PHARMACOLOGY
2nd SEMESTER
JAMIA HAMDARD

2. Pharmaco – Vigilance
■ Pharmakon = Medicine , Vigilance = To keep watch - Alert of
watchfulness In respect of danger; care; caution
■ Pharmacovigilance is a system to monitor the safety and effectiveness
of medicines and other Pharmaceutical products.
■ As per WHO: Pharmacovigilance as ‘’science and activities relating to
the detection, assessment, understanding, reporting and prevention of
adverse effects or any other possible drug- related problems’’.
Detection Assessment Understanding Reporting Prevention

3. AIMS
■ To improve patient care and safety
■ To improve public health and safety
■ To contribute to the assessment of benefit, harm ,effectiveness
and risk of medicines
■ To promote education and clinical training
■ To promote rational and safe use of medicine

4. RESPONSIBILITIES
■ Timely collection of data ,recording and notification
■ Appropriate assessments (data completeness ,
seriousness)
■ Expedited and periodic reporting
■ Creates appropriate structures for communication

5. WHY DO WE NEED
PHARMACOVIGILANCE
■ Humanitarian concern
■ ADR May cause sudden death
■ Promoting rational use of medicines and adherence
■ Ethics To know of something that is harmful to another person
who does not know, and not telling, is unethical

6. BASIC STEPS IN SETTING UPA
PHARMACOVIGILANCE CENTRE
1. Make contacts with the health authorities and with local, regional
or national institutions and groups, working in clinical medicine,
pharmacology and toxicology outlining the importance of the
project and its purposes.
2. Design a reporting form and start collecting data by distributing it
to hospital departments, family practitioners, etc.
3. Produce printed material to inform health professionals about
definitions, aims and methods of the pharmacovigilance system.
4. Create the centre: staff, accommodation, phone, word processor,
database management capability, bibliography etc.

7. 5. Take care of the education of pharmacovigilance staff with regard, for example,
to: data collection and verification
• interpreting and coding of adverse reaction descriptions
• coding of drugs
• case causality assessment
• signal detection
• risk management
6. Establish a database (administrative system for the storage and retrieval of data)
7. Organise meetings in hospitals, academia and professional associations,
explaining the principles and demands of pharmacovigilance and the
importance of reporting.
8. Promote the importance of reporting adverse drug reactions through medical
journals, other professional publications, and communications activities.
9. Maintain contacts with international institutions working in pharmacovigilance,
e.g. the WHO Department of Essential Drugs and Medicines Policy (Geneva)
and the Uppsala Monitoring Centre, Sweden.

8. ESTABLISHMENT OF PV
PROGRAMME IN INDUSTRY
■ Improve patient care and safety in relation to use of medicine
■ Protect patient from unnecessary harm by previously unrecognized drug hazards
■ Elucidating pre disposing factors
■ Refuting false safety signal
■ To quantifying risk in relation to benefit Aim

9. Scientific Characteristics
Clinical & Pre-Clinical Pharmacology Immunology
Epidemiolog
y
Toxicology

10. Pre-Marketing Pharmacovigilance
• Human Pharmacology • Safety, PK, Tolerability
• 20-100 Healthy Volunteer
Phase 1
• Therapeutic Exploratory • Safety, Efficacy
• 100-500 patient
Phase 2
• Therapeutic Confirmatory • Safety, Efficacy
• 1000-5000 patient
Phase 3
CLINICAL TRAILS

11. Post Marketing Surveillance
■ Spontaneous Reporting Unsolicited communication by healthcare
professionals or consumers to a company, regulatory authority or other
organisation (e.g., WHO, CDSCO etc.) that describes one or more
adverse drug reactions in a patient who was given one or more medicinal
products
■ Targeted Spontaneous Reporting To learn more about the ADR profile
of specific medicine(s) in your population Or To estimate the incidence of
a known ADR to a specific medicine in your population
■ Cohort Study Cohort study of adverse events associated with one or
more monitored medicines. It is related to class of medicine that has
previously caused ADRs Potentially significant adverse event observed
during post-marketing surveillance Like Retrospective, Prospective

12. A new plan for effective Implementation of
Pharmacovigilance In industry
Ensure patient
safety and product
efficacy
Evidence
generation and
management
Connected
manufacturing
distribution
Customer
management sales
and marketing
Part of the solution in healthcare delivery
Embrace rnulli0lJannel strategy and digital
systems Drive patient-centric approaches
FUTURE GOALS

13. CONTRACT RESEARCH
ORGANISATION
■ A CRO is an organisation contracted by another company to manage and lead
the company's trials, duties and functions.
■ CRO Identification and Selection
 Preparing study designs for each of the research studies to be outsourced.
 Determining which CROs should be considered as potential contractors.
 Soliciting cost and time proposals which include determining if the CROs
understands the study design and selecting those CRO to be consider further.
 Scheduling and conducting site visits to ensure the CROs are qualified.
 Negotiating time and cost for completion of research studies.
 Selecting the CROs and awarding the contracts for each study to be outsourced.

14. Function of CRO
■ Project Initiation Concept and feasibility
■ Product Development and Pre Clinical Testing Prototyping, Development,
Validation, Bench test etc.
■ Clinical Trial Protocol Development, Initiation & Monitoring, Investigation,
Data analysis, Reporting
■ Regulatory Submission
■ Post- Marketing Surveillance Monitoring

15. NATIONAL PHARMACOVIGILANCE
PROGRAMME
ORGANIZATION
Indian Pharmacopoeia Commission NCC PvPI
■ CDSCO Headquarter New Delhi
■ AEFI and ITSU MoHFW
■ NIB MoHFW Noida
■ Uppsala Monitoring Centre, Sweden
■ Adverse Drug Monitoring Centre
■ WHO India (Country Office)
■ National Health Programme
■ MoHFW Govt. of India

17. FUNCTION

18. ■ Goal
• To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health
of the Indian population.
■ Objectives
• To monitor Adverse Drug Reactions (ADRs) in Indian population
• To create awareness amongst health care professionals about the importance of ADR
reporting in India
• To monitor benefit-risk profile of medicines
• Generate independent, evidence based recommendations on the safety of medicines
• Support the CDSCO for formulating safety related regulatory decisions for medicines
• Communicate findings with all key stakeholders
• Create a national centre of excellence at par with global drug safety monitoring
standards

19. REFERENCES
1. Avani Patel, D Giles, Vidhya Thomas, Gurubasva rajaswamy PM, Riddhi Patel,
Pharmacovigilance: A Review, International Journal of Pharmaceutical and
Biological Archives. 2011.
2. Rajkumar Soni, Bikrant Kesari, A Review on Pharmacovigilance, International
Journal of Pharmaceutical Sciences Review and Research.
3. Pranay Wal, Rhidhima Mehra, Saista Razvi, Rachna Vajpayee,
Pharmacovigilance: Need for Indian Pharma Industry, International Research
Journal of Pharmacy, 2015.
4. Wanmali VV, Brahmane RI, Gupta R, Shinde B, Pharmacovigilance in India : the
way ahead