Individual Case Safety Report | What does Aggregate Reporting Mean | Clinical Trial

Individual Case Safety Report | What does Aggregate Reporting Mean | Clinical Trial
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Welcome to Episode 19 of our Pharmacovigilance Interview Q&A Series! In this episode, join Dr. Neema Bisht as she dives deep into the intricacies of ICSR and Aggregate Reports in Pharmacovigilance within the pharmaceutical industry.
Deep dive into pharmacovigilance! In this video, we cover two crucial report types for drug safety: Individual Case Safety Reports (ICSR) and Aggregate Reports. Discover how ICSRs provide detailed patient data to identify adverse drug reactions, and learn about Module 6 of Good Pharmacovigilance Practices (GVP). Explore Aggregate Reports, which evaluate drug safety profiles using cumulative data, focusing on benefit-risk assessments submitted to global regulators. Understand the purpose of Periodic Safety Update Reports (PSUR), Periodic Benefit Risk Evaluation Reports (PBRER), and Development Safety Update Reports (DSUR). Whether you're a pharmacovigilance professional or pharma enthusiast, this video offers essential insights into drug safety processes.
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Timestamps
1:26 - ICSR and Aggregate Report
1:52 - GVP
3:05 - GVP Module 6
3:48 - ICSR Timelines
5:43 - US FDA Timeline
7:35 - Regulatory Timeline
8:13 - Aggregate Reports
9:08 - Purpose of Aggregate Reports
12:21 - Conclusion