Day 1

Day 2

 

Day 3
Day 4
Resources

Please find the session links next to their corresponding agenda item.

Thursday, November 19

12:00– 1:00 PM 

Approval and Clearance Pathways for Medical Devices—Part 1
Allyson B. Mullen, Director, Hyman, Phelps & McNamara, PC
Ami E. Simunovich, Executive Vice President, Chief Regulatory Officer, Becton Dickinson (BD)

1:00 – 1:10 PM

Break

1:10 – 2:00 PM 

Approval and Clearance Pathways for Medical Devices—Part 2
Allyson B. Mullen, Director, Hyman, Phelps & McNamara, PC
Ami E. Simunovich, Executive Vice President, Chief Regulatory Officer, Becton Dickinson (BD)

Watch this session: https://fdli.zoom.us/rec/share/s5bqY7H0U7CzU4l6X-Nolr0w_UTbPbukkojXCNfqwQXrGuxP-u2b26idnRIk62ml.4dLdLyMw20GltJmB?startTime=1605805221000

2:00 – 2:15 PM

Break

2:15 – 3:30 PM 

Post-Market Considerations for Drugs and Devices
Elizabeth Mulkey, Associate, Goodwin Procter, LLP
Steven Tjoe, Associate, Goodwin Procter, LLP

Watch this session: https://fdli.zoom.us/rec/share/i1tUcRZ0lg4d0wPB-Xf0aE6jdcgnOO3Bmh07UgnQt2kc2CcJmIp31hYA6eWXUDeS.HFaa9_5XhTUU0r8s?startTime=1605813412000

3:30 – 3:45 PM

Break

3:45 – 4:45 PM

Expanded Access to Investigational Therapies for Drugs and Medical Devices
Richard Klein, Director, Expanded Access Programs & Policy, GE2P2 Global Foundation

Wacth this session: https://fdli.zoom.us/rec/share/igw6JX977V1LjP7S3OPuaOQUMeh2B7VNAfh5fNFOF0hvzMEvy5YRdvhqtLjJoThd.WZ60y1dS0ndeYlbT?startTime=1605818762000

4:45 – 5:15 PM

Networking Session: “Applying the Law to My Organization”

FAQ

This course is pending CLE approval in Virginia and Ohio. During the course, there will be periodic polling to ensure you are still listening. This will let us know if you completed the necessary hours to receive CLE credit. Please email [email protected] at the end of the conference to obtain forms.

Please find the session links next to their corresponding agenda item.

We will be using Zoom Webinars to conduct this Introductory course. If you have any technical issues throughout the course, please visit the Zoom Help Center here: https://support.zoom.us/hc/en-us/articles/206175806

Yes. Please contact Coleen Carney at [email protected] if you require dial-in numbers.