Course Objectives

This paper will provide an opportunity for the student to learn about development of Pharmacovigilance as a science, basic terminologies used in Pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing Pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.

CO PO mapping

CO PO Mapping:

Course Syllabus

MODULE-I
Introduction to Pharmacovigilance
 History and development of Pharmacovigilance
 Importance of safety monitoring of Medicine
 WHO international drug monitoring programme
 Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
 Definitions and classification of ADRs
 Detection and reporting
 Methods in Causality assessment
 Severity and seriousness assessment
 Predictability and preventability assessment
 Management of adverse drug reactions
Basic terminologies used in pharmacovigilance

 Terminologies of adverse medication related events
 Regulatory terminologies
MODULE-II
Drug and disease classification
 Anatomical, therapeutic and chemical classification of drugs
 International classification of diseases
 Daily defined doses
 International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
 WHO adverse reaction terminologies
 MedDRA and Standardised MedDRA queries
 WHO drug dictionary
 Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
 Basic drug information resources
 Specialised resources for ADRs
Establishing pharmacovigilance programme
 Establishing in a hospital
 Establishment & operation of drug safety department in industry
 Contract Research Organisations (CROs)
 Establishing a national programme
MODULE-III
Vaccine safety surveillance
 Vaccine Pharmacovigilance
 Vaccination failure
 Adverse events following immunization
Pharmacovigilance methods
 Passive surveillance – Spontaneous reports and case series
 Stimulated reporting
 Active surveillance – Sentinel sites, drug event monitoring and registries
 Comparative observational studies – Cross sectional study, case control study and
cohort study
 Targeted clinical investigations
Communication in pharmacovigilance
 Effective communication in Pharmacovigilance
 Communication in Drug Safety Crisis management
 Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

MODULE-IV
Safety data generation
 Pre clinical phase
 Clinical phase
 Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
 Organization and objectives of ICH
 Expedited reporting
 Individual case safety reports
 Periodic safety update reports
 Post approval expedited reporting
 Pharmacovigilance planning
 Good clinical practice in pharmacovigilance studies
MODULE-V
Pharmacogenomics of adverse drug reactions
 Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
 Paediatrics
 Pregnancy and lactation
 Geriatrics CIOMS
 CIOMS Working Groups
 CIOMS Form
CDSCO (India) and Pharmacovigilance
 D&C Act and Schedule Y
 Differences in Indian and global pharmacovigilance requirements

Session Plan

Session 1

Introduction to Pharmacovigilance

PDF-Introduction to Pharmacovigillance

Session 2

History of Pharmacovigilance

PDF-History of Pharmacovigillance

Session 3

Introduction to adverse drug reactions

PDF-ADR

Session 4

Basic terminologies used in Pharmacovigilance

PDF-Basic terminologies used in pharmacovigilance

Session 5

WHO international drug monitoring programme

PDF-WHO international drug monitoring programme

Session 6

ATC

PDF-ATC

Session 7

ICD

PDF-ICD

Session 8

DDD AND INN

PDF-DDD AND INN

Session 9

Drug dictionaries and coding in Pharmacovigilance

PDF-Drug dictionaries and coding in pharmacovigilance

Session 10

Information resources in Pharmacovigilance

PDF-Information resources in pharmacovigilance

Session 11

Establishing Pharmacovigilance programme

PDF-Establishing pharmacovigilance programme

Session 12

Vaccine safety surveillance

PDF-Vaccine safety surveillance

Session 13

Vaccine Pharmacovigilance

PDF-Vaccine Pharmacovigilance

Session 14

Pharmacovigilance methods

PDF-Pharmacovigilance methods

Session 15

Communication in Pharmacovigilance

PDF-Communication in pharmacovigilance

Session 16

Safety data generation

PDF-Safety data generation

Session 17

 ICH

PDF-ICH

Session 18

ICH Guidelines for Pharmacovigilance

PDF-ICH Guidelines for Pharmacovigilance

Session 19

Expedited reporting

PDF-Expedited reporting

Session 20

Periodic safety updates reports

PDF-Periodic safety updates reports

Session 21

Post approval expedited reporting

PDF-Post approval expedited reporting

Session 22

Pharmacovigilance planning

PDF-Pharmacovigilance planning

Session 23

Good clinical practice in Pharmacovigilance studies

PDF-Good clinical practice in pharmacovigilance studies

Session 24

Pharmacogenomics of Adverse Drug Reactions 

PDF-Pharmacogenomics of Adverse Drug Reactions

Session 25

Genetics related ADR with example focusing PK parameters

PDF-Genetics related ADR with example focusing PK parameters

Session 26

Drug safety evaluation

PDF-Drug safety evaluation

Session 27

CIOMS

PDF-CIOMS

Session 28

 CDSCO (India) and Pharmacovigilance

PDF-CDSCO and Pharmacovigilance

Session 29

 D&C Act and Schedule Y

PDF-D&C Act and Schedule Y

Session 30

Differences in Indian and global pharmacovigilance requirements

PDF-PvPI

Recommended Books (Latest edition):

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
3. Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones&Bartlett Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel,Sean Hennessy,Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal
11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK  Manna