Syllabus

Pharmacovigilance

 (Course Code: BP805ET)

Module 01                                                                                             10 Hour

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 02                                                                                         10 Hours

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 03                                                                                                 10 Hours

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 04                                                                                                   08 Hours

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 05                                                                                                                           07 Hours

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.