Welcome to our exclusive video workshop on Safety Surveillance in Clinical Trials, featuring Dr. Margaryta Mare, a leading expert in Safety and Pharmacovigilance.
This insightful workshop tackles the elephant in the room that many trials encounter: the potential financial and ethical fallout of inadequate safety management as well as the essential elements of safety surveillance process setup that every clinical trial professional needs to know.
Dr. Mare explores the evolution of safety surveillance, emphasizing the importance of understanding clinical trials safety data not just at the individual trial level, but across entire program populations.
This workshop will equip you with actionable insights to strengthen safety protocols, minimize risks, and ultimately ensure better outcomes for patients and your clinical trial program, in light of the draft 2021 FDA Guidance for Industry Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.
You’ll learn about:
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