Updates for 2020

FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2020 Introduction to Drug Law and Regulation Course will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience. Be sure to check the course website regularly for additional announcements and updates.

Overview

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 (FDAMA)
  • 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

Agenda

subject to change

Curriculum Advisor: Deborah M. Shelton, Partner, Arent Fox LLP 

Monday, November 9

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:35 PM
Overview of Drug Law and Regulation
Nathan A. Beaton
, Associate, Latham & Watkins LLP

1:35–1:45 PM
Break

1:45–3:00 PM
The New Drug Approval Process: Basic Concepts
Rebecca Dandeker
, Partner, Morgan, Lewis & Bockius LLP

3:00–3:15 PM
Break

3:15-4:30 PM
The New Drug Approval Process: New Drug Research and Development
Lee Rosebush
, Partner, BakerHostetler

 

 

 

Tuesday, November 10

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:15 PM
The New Drug Approval Process: NDA Submission and Review
Priya Jambhekar
, Independent Consultant, EAS Consulting Group

1:15–1:25 PM
Break

1:25–2:40 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Komal Karnik Nigam
, Senior Associate, Hogan Lovells US LLP

2:40–2:50 PM
Break

2:50–3:50 PM
Post-Approval Issues
Mantej (Nimi) Chhina, Senior Director and Head, Global Regulatory Policy, BioMarin Pharmaceutical Inc.

3:50–4:00 PM
Break

4:00–5:00 PM
Biologics and Biosimilars
Christopher M. Mikson
, Partner, DLA Piper LLP (US)

 

 

Thursday, November 12

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05 PM–1:05 PM
Regulation of Over-the-Counter (OTC) Drugs

Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP
Genevieve M. Razick, Associate, Arnall Golden Gregory LLP

1:05–1:15 PM
Break

1:15–2:15 PM
Regulation of Drug Manufacturing
Howard R. Sklamberg
, Partner, Arnold & Porter LLP

2:15–2:30 PM
Break

2:30–3:30 PM
Regulation of Drug Marketing
Jur Strobos, Partner, Potomac Law Group

3:30–3:45 PM
Break

3:45–5:00 PM
Violations and Enforcement
Peter J. Leininger
, Partner, King & Spalding LLP

5:00 PM
Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio 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.