Day 1

Day 2

 

Day 3
Resources

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

Tuesday, November 10

12:00 PM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

Enter this session: https://fdli.zoom.us/j/95582465377

12:05 – 1:15 PM 

The New Drug Approval Process: NDA Submission and Review
Priya Jambhekar
, Independent Consultant, EAS Consulting Group

Enter this session: https://fdli.zoom.us/j/95985156719

1:15 – 1:25 PM 

Break

1:25 – 2:40 PM 

The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Komal Karnik Nigam
, Senior Associate, Hogan Lovells US LLP

Enter this session: https://fdli.zoom.us/j/95505399378

2:40 – 2:50 PM

Break

2:50 – 3:50 PM

Post-Approval Issues
Mantej (Nimi) Chhina, Senior Director and Head, Global Regulatory Policy, BioMarin Pharmaceutical Inc.

Enter this session: https://fdli.zoom.us/j/93204674596

3:50 – 4:00 PM

Break

4:0 – 5:00 PM

Biologics and Biosimilars
Christopher M. Mikson
, Partner, DLA Piper LLP (US)

Enter this session: https://fdli.zoom.us/j/93797293679

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.