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

Register

Industry & Firms

$1199
  • +$400 for non-members

Non-Profit

$799
  • +$200 for non-members

Government

$799
  • +$200 for non-members

Academic

$799
  • +$200 for non-members

Student

$99
  • full-time students only
Register Now

 

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Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

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.

Previous Agenda

Day 1

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

8:35–9:35 AM
Overview of Drug Law and Regulation

9:35–9:50 AM
Break

9:50–11:15 AM
The New Drug Approval Process: Basic Concepts

11:15–12:15 PM
Lunch Break

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
Break

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

 

Day 2

8:30–9:45 AM
Biologics and Biosimilars

9:45–10:45 AM
Post-Approval Issues

10:45–11:00 AM
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
Lunch Break

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

3:30–3:45 PM
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.