Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for drugs
  • New Drug Application Process (NDA)
  • Biologics and the new regulatory pathway for biosimilars
  • Post-approval drug safety issues
  • Advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Kefauver-Harris Amendments
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FADAMA)
  • Food and Drug Administration Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Venue Sponsor:

Register Now

Industry & Firms

$1,199
  • +$400 for nonmembers

Non-Profit

$799
  • +$200 for nonmembers

Government

$799
  • +$200 for nonmembers

Academic

$799
  • +$200 for nonmembers

Student

$99
  • +$100 for nonmembers

Agenda

subject to change

Curriculum Advisor:  
Jur Strobos, Partner, Baker & McKenzie LLP

Thursday, November 2

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

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

Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–10:00 AM
Overview of Drug Law and Regulation

Marian J. Lee, Partner, Gibson Dunn & Crutcher LLP

10:00–10:15 AM
Networking and Refreshment Break

10:15–11:15 AM
New Drug Approval Process: Basic Concepts          

11:15 AM–12:15 PM
Networking Lunch

12:15-1:45 PM
New Drug Approval Process: New Drug Research and Development

Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP

1:45–3:20 PM
The New Drug Approval Process

Todd Halpern, Partner, Venable LLP

3:20–3:35 PM
Networking and Refreshment Break

3:35–5:00 PM
Abbreviated NDA, 505(b)(2) Applications, and Patent and Exclusivity Issues 

Michael K. Stern, Special Counsel, Covington & Burling LLP

Friday, November 3

8:00–8:30 AM
Continental Breakfast

8:30–9:45 AM
Biologics and Biosimilars

Jacqueline R. Berman, Associate, Morgan, Lewis & Bockius LLP

9:45–10:30 AM
Post-Approval Issues

10:30–10:45 AM
Networking and Refreshment Break

10:45–11:30 AM
Regulation of Over-the-Counter (OTC) Drugs

Diane McEnroe, Partner, Sidley Austin LLP
M. Christina Ricarte, Associate General Counsel, Purdue Pharma L.P.

11:30 AM–12:45 PM
Regulation of Drug Manufacturing

Brenda Carroll, Senior Associate, Alston & Bird LLP

12:45–2:00 PM
Networking Lunch

2:00–3:30 PM
Regulation of Drug Marketing

Sharon M. Bradley, Senior Attorney, FDA & Life Sciences Practice Group, King & Spalding LLP

3:30–3:45 PM
Networking and Refreshment Break

3:45–5:00 PM
Violations and Enforcement

Peter Leininger, Counsel, King & Spalding LLP

5:00 PM
Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Location and Overnight Accommodations

Course Location

Morgan, Lewis & Bockius LLP
1111 Pennsylvania Ave, NW
Washington, DC 20004

Parking and Public Transportation

Morgan, Lewis & Bockius is a short distance from Archives Navy Memorial Metro station on the green/yellow lines.

Parking is available at 415 11th Street NW for $24 per day and 220 E Street NW for $30 per day.

Overnight Accommodations

The following hotels are within walking distance of the meeting location:

Grand Hyatt Washington, 1000 H Street NW, Washington, DC 20001
Courtyard Washington Convention Center, 900 F Street NW, Washington, DC 20004
J.W. Marriott Washington, 1331 Pennsylvania Avenue NW, Washington, DC 20004
Hotel Monaco, 700 F Street NW, Washington, DC 20004

 

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.