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 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 by March 12 and SAVE!

Industry & Firms

$1199
  • +$400 for non-members
  • +$100 after 3/12/2020

Non-Profit

$799
  • +$200 for non-members
  • +$100 after 3/12/2020

Government

$799
  • +$200 for non-members
  • +$100 after 3/12/2020

Academic

$799
  • +$200 for non-members
  • +$100 after 3/12/2020

Student

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

Add This Must-Have Reference to Your Registration

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.

Preliminary Agenda

subject to change

Curriculum Advisor:

Deborah M. Shelton, Partner, Arent Fox LLP

 

Wednesday, April 15

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

11:15–12:15 PM
Networking Lunch

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

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

Thursday, April 16

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

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

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.

CLE credit hours go here.

Location and Overnight Accommodations

Course Location

Alston &  Bird LLP
950 F Street, NW
Washington, DC 20004

Overnight Accommodations

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