Webinar
FDA Regulatory and Enforcement Webinar Series
Wednesday, January 27 12:00 PM EDT to 1:00 PM EDT
Day One: Wednesday, January 27
Drugs & Biologics
Turning the Corner: A Review of FDA's Regulation of Drugs / Biological Products in 2020 and a Look Forward
This discussion will include:
GMP update and the impact of COVID-19 on inspection trends and enforcement
Analysis of critical supply chain factors, such as efforts to onshore more drug production, mitigating drug shortages, and an update to the Drug Supply Chain Security Act update
Cell and gene therapy products and a review of significant approval issues in 2020
Clinical trial regulation and expected post-COVID-19 impact
Potential priorities to keep your eye on with the new administration
If you missed this event, please access the recording here.
Day 2 Two: Thursday, January 28
Medical Devices
The Show Must Go On: FDA's Regulation of Medical Devices in 2020 and a Look Forward
This discussion will include:
Impact of COVID-19 on clinical trials, premarket review, and post-market oversight in the future
Trends in device enforcement in 2020 and critical indicators for 2021
Status of device establishment inspections and what inspections might look like as the FDA continues to adjust to the "new normal."
Continuing and intensifying debate surrounding the regulation of Laboratory Developed Tests
FDA's evolving regulation of digital health products
If you missed this event, please access the recording here.
EVENT INFORMATION
Day 1 - Turning the corner: Wednesday, January 27, 2021
Day 2 - The Show Must Go On: Thursday, January 28, 2021
Both Days: 9:00am - 10:00am PT / 12:00pm - 1:00pm ET / 5:00pm - 6:00pm GMT
CLE QUALIFICATIONS
We will be offering 2 hours of CLE credit for this program.
