Pharmacovigilance
Drug-safety monitoring; adverse drug reaction reporting; signal detection; national and global pharmacovigilance programmes.
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Course contents — unit by unit · PCI NEP 2020 BP705T
Unit 1 · Fundamentals of Pharmacovigilance 10 hrs
The definition, scope, aims and importance of pharmacovigilance; its historical development and the drug-safety disasters that shaped it; and the basic terminology of drug safety, including adverse events, adverse drug reactions and side effects.
Unit 2 · Pharmacovigilance Systems and Regulatory Framework 10 hrs
National and international pharmacovigilance systems — the Pharmacovigilance Programme of India (PvPI), the WHO Programme for International Drug Monitoring and the Uppsala Monitoring Centre; and the regulatory framework and reporting obligations that govern drug-safety monitoring.
Unit 3 · Adverse Drug Reactions 8 hrs
The classification and mechanisms of adverse drug reactions; predisposing factors; causality assessment scales including the WHO-UMC and Naranjo scales; and severity and preventability assessment.
Unit 4 · Pharmacovigilance Tools and Allied Disciplines 7 hrs
Safety databases and software including VigiBase, VigiFlow, Oracle Argus and OpenVigil; and immunovigilance together with the other disciplines of pharmacovigilance — materiovigilance, haemovigilance and vigilance of traditional medicines.
Unit 5 · Signal Detection, Risk Management and ICH 10 hrs
Signal detection and data-mining methods; risk communication, evaluation and management, including Risk Management Plans and REMS; and the ICH guidelines relevant to pharmacovigilance, together with periodic safety-update reporting.
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