The Association of Clinical Research Professionals

Research and Expanded Access in Pandemic Times

Because few alternatives exist, experimental COVID-19 therapies and diagnostics are being made available to patients and providers before clinical trials have established whether those products are safe and effective.

Participants in this recorded webinar will get an overview of the mechanisms through which this happens and will learn how this has affected researchers’ ability to generate substantial evidence of product effectiveness through high-quality clinical trials. Finally, with this context, presenters take a deeper dive into the FDA’s deliberations about clinical trials and approvals of COVID-19 vaccines.

This continuing education program is for clinical research, regulatory affairs, medical, scientific professionals, and anyone else who wants to understand the framework and practical implications of cutting-edge policy debates in this once-in-a-century public health emergency.

Clint Hermes, Counsel, Bass, Berry & Sims PLC
Nesrin Tift, Member, Bass, Berry & Sims PLC

Approved for 1.0 ACRP Contact Hours | Expires November 17, 2023