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SYLLABUS

Unit-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.

Unit-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

 Eudra Vigilance medicinal product dictionary Information Resources in Pharmacovigilance

 Basic drug information resources

 Specialised resources for ADRs syllabus for Pharmacy Council of India Establishing Pharmacovigilance Programme

 Establishing in a hospital

 Establishment & operation of drug safety department in industry

 Contract Research Organisations (CROs)

 Establishing a national programme.

Unit-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

Unit-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.

Unit-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