Tuesday, April 25

8:00-8:30 AM
Registration and Continental Breakfast

8:30-8:35 AM
FDLI Welcome and Announcements

8:35-9:35 AM
Overview of Drug Law and Regulation
Delia Ann Deschaine, Member of the Firm, Epstein Becker & Green, PC

9:35-9:50 PM
Networking Break

9:50-11:05 AM
The New Drug Approval Process: Basic Concepts
Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett

11:05-11:20 AM
Networking Break

11:20 AM-12:35 PM
The New Drug Approval Process: New Drug Research and Development
Susan S. Lee, Partner, Goodwin Procter LLP

12:35-1:35 PM
Networking Break

1:35-2:50 PM
The New Drug Approval Process: NDA Submission and Review
Charles G. Raver, Associate, Hyman, Phelps, & McNamara, PC

2:50-3:05 PM
Networking Break

3:05–4:20 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Alexandra Valenti, Partner, Goodwin Procter LLP (ANDA)

Wednesday, April 26

8:00-8:30 AM
Registration and Continental Breakfast

8:30-8:35 AM
FDLI Welcome and Announcements

8:35–9:50 AM
Post-Approval Issues

9:50–10:05 AM
Networking Break

10:05–11:05 AM
Biologics and Biosimilars
Christopher M. Mikson, Partner, DLA Piper LLP (US)

11:05–11:20 AM
Networking Break

11:20 AM–12:20 PM
Regulation of Over-the-Counter (OTC) Drugs
John F. Johnson, Senior Counsel, Shook, Hardy & Bacon LLP        

12:20–1:20 PM
Networking Lunch

1:20–2:30 PM
Regulation of Drug Manufacturing
Ted Lis, Counsel, Hogan Lovells US LLP

2:30–2:45 PM
Break

2:45–3:45 PM
Regulation of Drug Marketing
Sharon Bradley, Principal, Sharon Bradley Law PLLC

3:45–4:00 PM
Networking Break

4:00–5:00 PM
Violations and Enforcement
Rebecca Williams, Associate, Ropes & Gray LLP

5:00 PM
Adjournment