Day 1

 

Day 2
Day 3
Day 4
Resources

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

Wednesday, November 18

12:00– 12:15 PM 

FDLI Welcome and Announcements

 

12:15 – 1:15 PM 

Introduction to FDA Organization and Other Agencies
David L. Chesney, Principal and General Manager, DL Chesney Consulting

Watch this session: https://fdli.zoom.us/rec/share/5_hH43hmoX5P8-Z0KswyGl1rgLsWGURsYUv1H56G0tVJGQZx__oP7h1B7A7DQOth.siOuNOfQsmvG4zZ-?startTime=1605718945000

1:15 – 2:00 PM 

FDA in the Headlines and the Impact to Your Communities
Remy Brim, Vice President Regulatory Policy and Strategy, BGR Group and Fmr. Senior FDA Policy Advisor, Senate HELP Committee
Ryan Hohman, Vice President-Public Affairs, Friends of Cancer Research

Watch this session: https://fdli.zoom.us/rec/share/UiwWy3cNA7bcklzjEDgSwizqFaUE8mz76pCW4PtUM4176U1sPhdS3bHWtQoucPF0.H9gSL80xH4geaHeh?startTime=1605723351000

2:00 – 2:15 PM

Break

2:15 – 3:15 PM

New Drug Development Under an Investigational New Drug Application (IND)
Heidi Gertner, Partner, Hogan Lovells US LLP

Watch this session: https://fdli.zoom.us/rec/share/VxNeveoIBNYVJ9Kju5R7ZrLP4wYuEZhjAyNY0GWCHHyV-TKo-RwoyKYg1otLXmsh.EnL-1vyuswOfCTl1?startTime=1605726936000

3:15 – 3:30 PM

Break

3:30 – 5:00 PM

The FDA Approval Process for Drugs
Lee H. Rosebush
, Partner, BakerHostetler

Enter this session: https://fdli.zoom.us/rec/share/FCoKBJddOa9LQO9n2qo9UrzFBwJrY924knJhUiIJ9M9Jd78QLUpI6ZnHWp6oEZEV.IrjobKUqseGhCyq_?startTime=1605731409000

5:00 – 5:30 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.