Certification in Pharmacovigilance

Duration: 2 months theory + 2 months onsite training

S. No	Topic	Duration (Hours)
1	History of Clinical Research and Drug Development Process	2
2	Introduction to the Ethical and Regulatory Frameworks of Clinical Research	2
3	Fundamentals of Health Research and Evaluation Methods	6
4	Overview of ICH E6-ICH GCP	10
5	Overview of Pharmacovigilance principles, history, and significance.	4
6	Role of Pharmacovigilance in drug development, approval, and post-marketing surveillance	4
7	Regulatory Framework and Guidelines	4
8	Understanding global regulatory requirements and guidelines (e.g., FDA, EMA, and ICH)	2
9	Principles of adverse event (AE) and adverse drug reaction (ADR) reporting	2
10	Methods for collecting, recording, and evaluating AE/ADR data	2
11	Signal detection and management	2
12	Development and implementation of risk management plans	2
13	Medical evaluation and causality assessment of adverse reactions	2
14	Ethical considerations in Pharmacovigilance practice	2
15	Legal responsibilities and obligations related to drug safety reporting	2
16	Case Studies	2