Hyatt Regency New Brunswick
Two Albany Street
New Brunswick, NJ 08901

Agenda


December 11th


8:00 AM
Registration and Continental Breakfast

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

8:35 - 9:20 AM
Origins and Overview of the Organizational Structure of the Food and Drug Administration (FDA) and the Regulation of Drugs

Michael Wigotsky, Senior Associate, DLA Piper LLP

  • Review the legislation that is the framework for today’s legal and regulatory requirements of drugs
  • Consider how the healthcare reform legislation affects FDA regulation

9:20 - 10:05 AM
FDA’s Regulatory Processes

Jennifer Romanski, Principal, Porzio, Bromberg & Newman, P.C.

  • Recount the legal and regulatory sources that shape FDA’s regulation

10:05 - 10:25 AM
Refreshment and Networking Break

10:25 - 11:30 AM
The New Drug Approval Process: Basic Concepts

Peter Reichertz, Partner, Sheppard Mullin Richter & Hampton LLP

  • Define “drug”
  • Differentiate between a drug, biologic, food, dietary supplement, medical device, cosmetic, and combination product.

11:30 AM - 12:30 PM
Networking Lunch

12:30 - 1:55 PM
The New Drug Approval Process: New Drug Research and Development

David Chesney, Vice President and Practice Lead, Strategic Compliance Services, Parexel International

  • Recognize the requirements of Good Laboratory Practices and Good Clinical Practices
  • Explore the fast track review process
  • Pediatric Testing Requirements
  • Clinical Trials Registry

1:55 - 3:20 PM
The New Drug Approval Process: NDA Submission and Review

Peter Reichertz, Partner, Sheppard Mullin Richter & Hampton LLP

  • Review the content and organization of a New Drug Application 
  • Become familiar with drug user fees – purpose and rates

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

Joy Liu, Partner, Ropes & Gray LLP, Board Member, FDLI

  • Differentiate between an NDA and an ANDA 
  • Define 505(b)(2) Applications
  • Review patent and exclusivity provisions 
5:00 PM
Adjournment

December 12th

8:00 AM
Registration and Continental Breakfast

8:30 - 9:00 AM
Biologics and Biosimilars

Freddy Jimenez, Assistant General Counsel, Johnson & Johnson

  • What is a Biologic?
  • Biologics License Application (BLA) Approval Standards
  • What is a Biosimilar?
  • Biosimilar Approval Standards

9:00 - 9:45 AM
Post-Approval Issues

Freddy Jimenez, Assistant General Counsel, Johnson & Johnson

  • Define Adverse Drug Experience (ADE) Reports
  • Explore examples of post-approval safety issues

9:45 - 10:50 AM
Over-the-Counter (OTC) Drugs

Debra Dunne, Partner, Shook, Hardy & Bacon LLP

  • Compare prescription drug and OTC drug categories
  • Discuss OTC switches

10:50 - 11:05 AM
Refreshment and Networking Break

11:05 AM - 12:35 PM
Regulation of Drug Manufacturing

David Chesney, Vice President and Practice Lead, Strategic Compliance Services, Parexel International

  • Examine drug Current Good Manufacturing Practices (cGMPs), and define “adulteration” and “misbranding”
  • Review the different types of inspections, and the differences between foreign and domestic inspections
  • Explore the elements of a 483 observation and the components involved with closing out an inspection

12:35 - 1:35 PM
Networking Lunch

1:35 - 3:15 PM
Regulation of Drug Marketing

Lauren Silvis, Partner, Sidley Austin LLP

  • Review the scope of FDA authority of drug promotion and advertising
  • Define “label” and “labeling” and “false and “misleading”
  • Discuss off-label issues and Direct-to-Consumer (DTC) Advertising
  • Gain insight on FDA’s social media guidance

3:15 - 3:30 PM
Refreshment and Networking Break

3:30 - 5:00 PM
Violations and Enforcement

Katie Topolewski, Associate General Counsel, Auxilium Pharmaceuticals

  • Explore FDA’s enforcement jurisdiction and the 2009 Enforcement Initiatives
  • Discuss enforcement tools and procedures
  • Review the various prohibited acts and penalties
  • Become familiar with issues involving drug imports and exports

5:00 PM
Adjournment