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Events

Webinar

FDA Regulatory and Enforcement Webinar Series

Wednesday, January 27, 2021 - Wednesday, January 27, 2021
12:00 pm New York - 1:00 pm New York

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

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


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.


Practice Areas


Contributors

Image: Peter V Lindsay
Peter V Lindsay
Partner, Litigation Department
Image: Brady K Mickelsen
Brady K Mickelsen
Associate, Litigation Department
Image: Jesselyn C Pe
Jesselyn C Pe
Associate, Litigation Department
Image: Nathan Sheers
Nathan Sheers
Partner, Litigation Department