Chicagoland Chapter: Webinar Replay: Research and Expanded Access in Pandemic TimesClick Here to purchase Contact HoursSpeakers:
Clint Hermes, Counsel, Bass, Berry & Sims PLC
Nesrin Tift, Member, Bass, Berry & Sims PLC
(non-affiliated) Program Agenda:
- 6:00 – 7 pm – Webinar Replay Presentation
- 7:00 – 7:15 pm – Q&A
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. Attendees 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, we will do a deeper dive into the FDA’s deliberations about clinical trials and approvals of COVID-19 vaccines.
This webinar 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. Upon completion of this Seminar, attendees should be able to:
- Identify pathways for unapproved drugs/devices
- Recognize regulatory framework for doing research during COVID-19
- Describe COVID-19 therapies and vaccines
- Project Managers
- Regulatory Affairs/Compliance
- Medical Monitors, Medical Officers, Project Physicians
- Clinical Research Administrators
Registration Cost: $0 Chapter Members; $0 ACRP Members; $10 Non-Members
Contact hours: 1.0 ACRP Contact Hours
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program.
Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Refund Policy: No refunds
Level: Not specified