Periodic Safety Update Report|Development Safety Update Report|Clinical Trial
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Welcome to Episode 20 of our Pharmacovigilance Interview Q&A Series! In this episode, join Dr. Neema Bisht as she dives deep into the intricacies of Aggregate Reports in Pharmacovigilance within the pharmaceutical industry.
Join us as we explore the world of pharmacovigilance and the crucial role of aggregate reports. Learn about the different types of reports-PSUR, PBRER, and DSUR-and their importance in monitoring drug safety and efficacy. Discover the purposes of each report and their submission frequencies in various regions. Stay tuned for more insights into pharmacovigilance and the pharmaceutical industry. Ensure compliance and enhance your knowledge with CareerInPharma! Like, comment, and subscribe for more expert content on drug safety!
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Timestamps
2:16 - Aggregate Reports
2:49 - Individual Case Safety Report
4:14 - Different Types of Aggregate Reports
4:38 - Pre Authorisation and Post Authorisation Report
5:59 - Periodic Adverse Drug Periodic Report
10:00 - Periodic Benefit Risk Evaluation Report
12:00 - Purpose of DSUR
15:13 - Guideline to prepare PEBRER
18;34 - Conclusion