The regulatory environment for the advertising, promotion and labeling
of medical devices, prescription drugs and biologic products continues
to evolve. Everyone operating in the healthcare field needs an
understanding of the regulatory frameworks and industry best practices.
This helps to ensure that consumers have adequate knowledge regarding
the appropriate use of healthcare products. Hear from leaders in
industry, agencies and the legal profession as they share their
expertise through didactic presentations, discussions and case studies.
The program provides an overview of current guidelines and expectations
for the US and EU and how they impact how you communicate with
prospective and end users.
Learning Objectives
- Summarize latest regulations, enforcement actions, guidelines
and trends affecting the advertising and promotion of medical devices,
drugs and biologics
- Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion
- Discover regulatory applications through interactive case studies
Who Should Attend
- Early to mid-level regulatory professionals involved in advertising and promotion of health products for the US or the EU
- Regulatory consultants
- Compliance specialists
- Food and drug lawyers
- Marketing representatives
- Medical device attorneys
- Medical communications professionals
Learning Level(s): Basic, Intermediate
RAC Points: 6
Lead Faculty:
Bradley Merrill Thompson, JD, MBA, RAC, attorney,
Epstein Becker & Green PC, is in the healthcare and life sciences
practice in the firm's Washington, DC office and is strategic counsel
with EBG Advisors, Inc. There he counsels medical device and drug
companies on a wide range of FDA regulatory, reimbursement and clinical
trial issues. For trade associations, Thompson has served as counsel to
AdvaMed for payment issues, as general counsel to the Combination
Products Coalition and as counsel and secretary for the Indiana Medical
Device Manufacturers Council. He has taught food and drug law as an
adjunct professor at the Indiana University Law School and Columbia Law
School. Thompson also serves as co-chair of the Food & Drug Law
Committee of the Administrative Law Section of the American Bar
Association. Thompson was included in 100 Notable People in the Medical
Device Industry (Medical Device & Diagnostics Industry, June 2004),
and has been named a "SuperLawyer" in Indiana.