Explore the essentials of drug law and regulation and gain a comprehensive understanding of the various 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)
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FDAMA)
  • Food and Drug Administration Amendments Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic Drug User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of drug law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

Register

Industry & Firms

$1199
  • +$400 for nonmembers

Non-Profit

$799
  • +$200 for nonmembers

Government

$799
  • +$200 for nonmembers

Academic

$799
  • +$200 for nonmembers

Student

$99
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2017 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. Select the “bundle option” to take advantage of this offer. The book will be immediately shipped directly to you.

Agenda

subject to change

Wednesday, April 26

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

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

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

Jur Strobos, Partner, Baker & McKenzie LLP

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

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

Jennifer Davidson, Partner, Kleinfeld, Kaplan & Becker, LLP

11:15 AM–12:15 PM
Networking Lunch

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

Kaiser Aziz, Senior Consultant, EAS Consulting Group, LLC

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

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

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

Nathan Beaver, Partner, Foley & Lardner LLP
David Rosen, Partner, Foley & Lardner LLP

Thursday, April 27

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

8:30–9:45 AM
Biologics and Biosimilars

Deborah Shelton, Partner, McCarter & English LLP

9:45–10:30 AM
Post-Approval Issues

Jennifer Zachary, Partner, Covington & Burling LLP
Mingham Ji, Associate, Covington & Burling LLP

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

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

Rikin Mehta, Head of US Regulatory Policy, Pfizer, Inc.

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

James Johnson, Partner, Hogan Lovells US LLP

12:45–2:00 PM
Networking Lunch

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

Katlin Backfield, Attorney, Backfield LLC

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

3:45–5:00 PM
Violations and Enforcement

William Gould, Partner, Holland and Knight LLP

5:00 PM
Adjournment

Speaker Biographies

Speaker biographies will be posted as they become available.

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

Foley and Lardner
3000 K St NW # 600
Washington, DC 20007

Overnight Accommodations

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

The Westin Georgetown, 2350 M Street NW
Four Seasons Hotel, 2800 Pennsylvania Avenue NW
Avenue Suites Georgetown, 2500 Pennsylvania Avenue NW
Residence Inn, 801 New Hampshire Avenue

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