Introduction to Drug Law and Regulation

April 24–25, 2024   Washington, DC   In-Person Course

Preliminary Agenda

Agenda Subject to Change
All times are in Eastern Time

2024 Curriculum Advisor:
David R. Joy, Partner, Keller and Heckman LLP

Wednesday, April 24

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

9:35-9:50 AM
Networking Break

9:50-11:05 AM
The New Drug Approval Process: Basic Concepts

11:05-11:20 AM
Networking Break

11:20 AM-12:35 PM
The New Drug Approval Process: New Drug Research and Development

12:35-1:35 PM
Networking Break

1:35-2:50 PM
The New Drug Approval Process: NDA Submission and Review

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

Thursday, April 25

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

11:05–11:20 AM
Networking Break

11:20 AM–12:20 PM
Regulation of Over-the-Counter (OTC) Drugs

12:20–1:20 PM
Networking Lunch

1:20–2:30 PM
Regulation of Drug Manufacturing

2:30–2:45 PM
Break

2:45–3:45 PM
Regulation of Drug Marketing

3:45–4:00 PM
Networking Break

4:00–5:00 PM
Violations and Enforcement

5:00 PM
Adjournment