GLOBAL PHARMACOVIGILANCE SCHOOL

Introduction and scope of Pharmacovigilance

Good Pharmacovigilance practices (GVP)

Adverse Events (AEs)

Adverse Drug Reactions (ADRs)

Types of Adverse Drug Reactions (ADRs)

Product quality complaints (PQCs)

Why are pharmacovigilance and reporting ADRs important?

Patient Risk Factors for Adverse Drug Reactions

Aims and objectives of Pharmacovigilance

What is the need of Pharmacovigilance

Clinical trials and types

Department of Pharmacovigilance & Drug Information

Serious adverse reactions criteria with examples

ADRs in children

ADRs in Pregnant women and in Breastfeeding

ADRs in the elderly

Pregnancy and congenital abnormalities

Adverse incidents involving medical devices

Yellow card (Serious warning)

Reporting forms of various countries

Regulatory Authorities and their roles

Validity and essential criteria for an ICSRs reporting

Invalid ICSRs and their importance

Special reporting situations

Expedite reporting

Report Types in Pharmacovigilance ICSRs

Causality or Causal relationship (Attribution) determinination

SUSAR (Suspected unexpected serious adverse reaction)

Drug Medication errors

Dechallenges and Rechallenges

Reference Safety Information (RSIs) documents

Reporting timelines and penalties (Practical)

Fields or entries related to Pharmacovigilance database (Practical)

Age groups and Pharmacovigilance

Glossary of Terms

Adverse events reporting forms formats (Practical)

Examples of adverse events reports and validity (Practical)

Narrative writing guidelines (Practical)

Narrative formats (Practical)