BP705TSemester 73 creditsTheoryKEY SUBJECT

Pharmacovigilance

Complete unit-wise syllabus for BP705T as per the PCI B.Pharm NEP 2020 curriculum (Semester 7 — Pharmacovigilance + Regulatory + Research).

URL:https://pharmacode.in/syllabus/semester-7/bp705t-pharmacovigilance/

Unit-wise Syllabus

5 Units

Introduction to Pharmacovigilance and Drug Safety9 Hours

Definition, objectives, and scope of pharmacovigilance; historical background: thalidomide disaster, chloramphenicol aplastic anaemia, fen-phen withdrawal — lessons learnt
Drug-related problems and medication safety: medication errors, subtherapeutic dosing, drug-drug interactions; distinction between ADRs and medication errors
Drug safety considerations in special populations: paediatrics (Reye's syndrome), geriatrics (Beers criteria), pregnancy (teratogenicity categories), renal/hepatic impairment

Pharmacovigilance Systems and Regulatory Framework9 Hours

Objectives and functions of pharmacovigilance; WHO Uppsala Monitoring Centre (UMC) and VigiBase; international collaboration in drug safety monitoring
Methods of pharmacovigilance data collection: spontaneous reporting, cohort event monitoring, prescription event monitoring, case-control surveillance, healthcare database analysis
Regulatory framework: ICH E2A (expedited reporting), ICH E2C (PSURs), ICH E2D (post-approval safety reporting), ICH E2E (pharmacovigilance planning); EMA guidelines; FDA FAERS database

Adverse Drug Reaction Classification and Signal Detection9 Hours

ADR classification: WHO classification (Type A-F); DoTS (Dose, Time course, Susceptibility) classification; causality assessment methods — WHO-UMC scale, Naranjo algorithm, Karch and Lasagna criteria
Severity assessment: mild, moderate, severe, life-threatening (SAE definition); preventability assessment: Schumock and Thornton scale
Signal detection methods: disproportionality analysis — PRR (Proportional Reporting Ratio), ROR (Reporting Odds Ratio), BCPNN; data mining in pharmacovigilance databases; online reporting mechanisms

Risk Management and Vaccine Pharmacovigilance9 Hours

Risk management plans (RMP): structure and content; risk minimisation measures (routine and additional); REMS (Risk Evaluation and Mitigation Strategy) in USA; EU risk management system
Drug labelling updates due to pharmacovigilance signals; Dear Healthcare Provider letters; market withdrawal decisions; communication of drug safety information
Vaccine pharmacovigilance (vaccinovigilance): adverse events following immunization (AEFI) — classification (programmatic, vaccine-induced, coincidental); AEFI surveillance; Brighton Collaboration case definitions; COVID-19 vaccine safety monitoring

Indian Pharmacovigilance Programme and Good Pharmacovigilance Practices9 Hours

Pharmacovigilance Programme of India (PvPI): structure, national coordination centre (IPC Ghaziabad), ADR monitoring centres (AMCs); Vigiflow reporting; PvPI achievements and publications
ICH E2F Development Safety Update Reports (DSURs); Periodic Safety Update Reports (PSURs): structure, cumulative analysis, benefit-risk evaluation; signal management process
Good Pharmacovigilance Practices (GVP) modules (EU): Module I (pharmacovigilance systems), Module VI (management and reporting of ADRs), Module IX (signal management); pharmacovigilance audit; role of pharmacist in PV

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