Welcome to FDLI
The Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.
Emerging Realities in REMS
Planning and Execution
February 16 | Park Hyatt Washington Hotel
Washington, DC
The Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategies (REMS) program turns two years old and with it comes a number of issues, challenges and opportunities, not the least of which is the draft guidance. This conference, developed for intermediate-level learners working in the drugs and biologics industries, will examine the meaning of what... Read more.
Introduction to Drug Law
and Regulation:
A Program on Understanding
How the Government Regulates
the Drug Industry
February 17-18 | Park Hyatt Washington Hotel
Washington, DC
This is the premier course to help you and your organization understand FDA regulations for drug products. By attending this two day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. Read more.
Introduction to Medical
Device Law and Regulation:
A Program on Understanding How the Government Regulates the Medical Device Industry
March 8-9 | The Madison Hotel
Washington, DC
In this interactive two-day program, you will learn the essential elements of medical device regulations in a systematic and comprehensive way. The first day will focus on the legal framework, FDA’s organization and pre-market requirements and the second day will focus on postmarket requirements, the Quality System Regulation (QSR), adverse events, and promotion... Read more.