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.

venue sponsor

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for drugs
  • New Drug Application (NDA) process
  • 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

Register by October 3 and SAVE!

Industry & Firms

$1,199
  • +$400 for non-members
  • +$100 after 10/3/2019

Non-Profit

$799
  • +$200 for non-members
  • +$100 after 10/3/2019

Government

$799
  • +$200 for non-members
  • +$100 after 10/3/2019

Academic

$799
  • +$200 for non-members
  • +$100 after 10/3/2019

Student

$99
  • full-time students only
  • transcripts required
Register

A Valuable Reference
Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 6th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

Agenda

subject to change

Curriculum Advisor: Michael K. Stern, Of Counsel, Covington & Burling LLP

 

Thursday, November 7

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

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

10:15–11:15 AM
The New Drug Approval Process: Basic Concepts
Deborah M. Shelton, Partner, Arent Fox LLP

11:15–12:15 PM
Networking Lunch

12:15-1:45 PM
The New Drug Approval Process: New Drug Research and Development
Alexander J. Varond, Associate, Goodwin Procter LLP

1:45–3:20 PM
The New Drug Approval Process: NDA Submission and Review

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

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

Friday, November 8

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

Friday, November 8

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

8:30–9:45 AM
Biologics and Biosimilars

9:45–10:45 AM
Post-Approval Issues
Mantej (Nimi) Chhina, Senior Director, Regulatory Policy & FDA Engagement, BioMarin Pharmaceutical Inc.

10:45–11:00 AM
Networking and Refreshment Break

11:00 AM–12:00 PM
Regulation of Over-the-Counter (OTC) Drugs

12:00–1:00 PM
Regulation of Drug Manufacturing

1:00–2:00 PM
Networking Lunch

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

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

3:45–5:00 PM
Violations and Enforcement
Peter J. 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

Latham & Watkins
555 11th Street, NW
Washington, DC 20004

Parking and Public Transportation

Coming soon.

 

Overnight Accommodations

A block of rooms has been reserved at the Mayflower Hotel for course attendees at the special group rate of $379/night, not inclusive of taxes. The Mayflower is approximately a 10 minute drive or 20 minute walk from the course location. Reservations can be made online and must be received by October 16, 2019 to receive the group rate. After this date, it is at the hotel’s discretion whether to accept additional reservations, which will be subject to prevailing rates and availability.

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