BP705T · Semester 7 · B.Pharm
Unit II — Pharmacovigilance Systems and Regulatory Framework
Pharmacovigilance
This study page introduces Pharmacovigilance Systems and Regulatory Framework in Pharmacovigilance (BP705T), B.Pharm Semester 7. Read the selected definitions and short notes below, then download the full unit PDF.
Topics in this unit
- PV Systems — Objectives, Functions and Data Collection Methods
- Global Pharmacovigilance Systems — WHO, CIOMS, USFDA and EMA
- Pharmacovigilance Programme of India (PvPI) and ADR Monitoring Centres
Definitions and short notes
Selected extracts from this unit’s notes. Download the full PDF below for the remaining topics and examples.
Pharmacovigilance (PV)
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. In simple words: the job of watching medicines after they are sold to the public, catching their side effects, studying them, and taking action so patients are not harmed.
Unit PDF · page 2
Adverse Drug Reaction (ADR)
A harmful, unwanted response to a medicine that happens at the normal dose used for treatment. Example: liver damage after taking a normal dose of a painkiller.
Unit PDF · page 2
Download notes
Save the PDF for offline reading. On some browsers, the file opens first; use the PDF viewer’s download button to save it.
For education and exam preparation only, not medical advice or current regulatory guidance.