PHARMACOVIGILANCE
About Course
Focused on drug safety and regulatory compliance, this course prepares students for the pharmaceutical industry. It follows international standards for monitoring the effects of medicines. The first month covers the science of adverse drug reactions, while the second month focuses on actual case processing and reporting as per FDA/EMA standards.
Course Content
Month 1: Theory & Concepts (Monday – Friday Classes)
Module 1: Introduction to Pharmacovigilance
Module 2: ADR Case Processing
Module 3: Medical Coding
Module 4: Narrative Writing
Module 5: Regulatory Reporting
Module 6: Signal Detection
Month 2: Industry-Level Projects
Project 1: Individual Case Safety Report (ICSR)
Project 2: Safety Signal Analysis
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