Basics of Pharmacovigilance: Adverse Drug Reactions & Risk Management
Автор: RV Sivaji Vlog
Загружено: 2025-10-22
Просмотров: 67
Welcome to this beginner-friendly guide to pharmacovigilance—the science of monitoring, assessing, and preventing adverse effects of medicines.
✅ What is pharmacovigilance?
✅ Terminologies - ADR, AE, SUSAR, Relatedness, Listedness, Suspect, Aggregate report, Health authority, Clinical trial, Post marketing surveillance, Signal detection
✅ Why drug safety matters for public health
✅ Key terms: ADRs, signal detection, case processing
✅ How global and Indian systems (PvPI, WHO, CDSCO) work
✅ The ethical responsibility behind safe medicine use
Timestamps
Introduction : 00:00
Drug Development Basics : 00:42
Preclinical Studies : 01:09
IND Application: 03:12
Pharmacovigilance Definition: 04:14
Human Clinical Trials: 04:35
Pharmacovigilance in Clinical Trial: 05:57
SUSAR: 10:34
Modules of Reporting: 10:57
NDA - New Drug Application: 11:16
Phase IV: 11:47
Pharmacovigilance in Post Marketing Surveillance: 05:57
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