jueves, 21 de septiembre de 2023

Two-Day Virtual Public Meeting: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies

During the COVID-19 public health emergency (PHE), the U.S. Food and Drug Administration provided recommendations to mitigate the disruption of clinical studies. Join us for a virtual public meeting on October 18 and 19, 2023, in collaboration with the Clinical Trials Transformation Initiative to discuss these recommendations and to discuss advanced planning approaches to mitigate the disruption of clinical studies during disasters and PHEs. The public meeting will take place from 10 a.m. to 1:30 p.m. ET on both days and is free to attend. The meeting agenda can be viewed here. https://duke.zoom.us/meeting/register/tJAvcO-oqD4vE9Ov1Vv-A3SoItVhL7Rhg66T?utm_medium=email&utm_source=govdelivery#/registration The two-day virtual public meeting will include presentations, panels and discussion opportunities led by FDA, pharmaceutical and medical device industries, academia, research study teams, patients, patient advocacy groups and other federal agencies, who will share their experiences and best practices including approaches they used to effectively navigate disruptions to clinical studies during the COVID-19 PHE. This public meeting fulfills a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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