Pharmacovigilance
6 videos · last 6 months shuffled daily, then older videos newest first
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35:58 Safety That Scales: Practical Clinical Safety Strategies for Early-Stage Biotechs
An HRB TMRN session on sponsor responsibilities, SAE and SUSAR reporting, safety governance for small organizations, and maintaining effective CRO oversight.
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44:20 Safety Reporting Under the EU Clinical Trials Regulation
Ergomed's PrimeVigilance outlines the safety side of the EU Clinical Trials Regulation 536/2014, including how it differs from the old Directive, transitional arrangements and new reporting duties to authorities and ethics committees.
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10:10 CTCAE - Explaining Acronyms and How to Use Them in Clinical Development
Oncology consultant Johannes Wolff explains the Common Terminology Criteria for Adverse Events, which grade adverse-event severity in oncology drug development, as part of a teaching series for clinical drug developers.
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31:04 Season 1 Episode 7: The Safety Nucleus: From Compliance to Strategic Enabler
Veeva's Safety [R]Evolution podcast talks to Pav Rishiraj of Ipsen about pharmacovigilance and moving from reactive to predictive safety to improve benefit-risk analysis.
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13:29 Best Practices in Adverse Event Reporting
RQM+ safety management manager Melanie Miller covers adverse event definitions for devices versus drugs, global reporting requirements and timelines, and the minimum data set for reportable events.
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2:39 How Does EMA Ensure the Safety of Medicines in the EU?
The European Medicines Agency on the day-to-day work of its safety committee, the PRAC, and how it works with national regulators to monitor medicines and vaccines in the EU.