Date: October 18 - 19, 2023 Day1: Wed, Oct 18 10:00 AM - 1:30 PM ET Day2: Thu, Oct 19 10:00 AM - 1:30 PM ET

About the Meeting: 

The Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting on October 18-19, 2023, to discuss recommendations provided by FDA during the COVID-19 public health emergency to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards

The meeting fulfills a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) and will discuss potential strategies for advanced planning to mitigate clinical study disruptions in the future. 

Meeting Information & Registration: 

Meeting Dates: October 18-19, 2023 

Please register for the meeting here. We invite meeting registrants to submit questions for speakers and panelists in advance of the meeting. Please submit your questions through the online survey

The meeting will also include discussions with representatives from FDA, pharmaceutical and medical device industries, academia, research study teams, patients, patient advocacy groups and other federal agencies, who will share the experiences, best practices and approaches they used to effectively navigate disruptions to clinical studies during the COVID-19 public health emergency. An agenda for the meeting can be viewed here

The free two-day virtual public meeting will be held on October 18-19, 2023, from 10 a.m.-1:30 p.m. ET on both days.