BP805E. PHARMACOVIGILANCE Books
Monitoring, detecting, and preventing adverse drug reactions, ensuring safe and effective use of medications through:
– Adverse event reporting and analysis
– Risk management and mitigation
– Regulatory compliance and safety surveillance”
Course Content
Unit Title
Content
UNIT-I
- Introduction to Pharmacovigilance
- Introduction to adverse drug reactions
- Basic terminologies used In pharmacovigilance
UNIT-II
- Drug & disease classification
- Drug dictionaries and coding in pharmacovigilance
- Information resources in pharmacovigilance
- Establishing pharmacovigilance programme
UNIT-III
- Vaccine safety surveillance
- Pharmacovigilance methods
- Communication in pharmacovigilance
UNIT-IV
- Safety data generation
- ICH Guidelines for Pharmacovigilance
UNIT-V
Pharmacogenomics of adverse drug reactions
Drug safety evaluation in special population
CIOMS
CDSCO (India) and Pharmacovigilance
Learning Objectives
- Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle
- ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
- CIOMS requirements for ADR reporting
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