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BP804 ET PHARMACEUTICAL REGULATORY SCIENCE Question Bank
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”
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