Virtual Program: US Regulation of Advertising, Promotion and Labeling for Medical Devices (2-part Series)

5.0
RAC Credits
Tuesday, 18 June 2019 (12:00 PM) - Thursday, 20 June 2019 (2:00 PM)

Registration Information


Early Bird ends 15 May After May 15
Member $399 $499
Nonmember $499 $599

* Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.


Schedule

Part 1: Tuesday, 18 Jun from 12:00–2:30 pm Eastern 

Part 2: Thursday, 20 Jun from 12:00–2:00 pm Eastern

Program Agenda


Speakers

Bradley Thompson, JD, RAC, member, Epstein, Becker & Green, P.C.

Stuart Kim, JD, MS, vice president & associate general counsel, regulatory, Cardinal Health

Joanne Hawana, MS, JD, member, Mintz Levin

Carol Cooper, MS, RAC, IM(ASCP), RM(AAM), principal consultant, CM Cooper and Associates


Hear from industry leaders, regulatory experts and the legal profession as they share their expertise through presentations, discussions and case studies. This program examines current guidelines and expectations for medical device advertising, promotion and labeling in the US and how they impact the way you communicate with prospective and end users. 

Learning Objectives

  • Summarize regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices
  • Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion, with specific attention on FDA’s regulation of social media promotion
  • Examine the current state of off-label promotion
  • How to evaluate and use real-world data and real-world evidence 
  • Discover regulatory applications through case studies
  • Guidance on device combination products containing drugs or biologics

Who Should Attend

  • Early to mid-level regulatory professionals involved in advertising and promotion of medical devices for the US market
  • Regulatory consultants 
  • Compliance specialists 
  • Food and drug lawyers 
  • Marketing representatives 
  • Medical device attorneys
  • Medical communications professionals
  • Medical affairs
  • Medical writing
  • Medical Science Liaisons (MSLs)
  • Clinical research professionals


For the cancellation policy, please see FAQ


Need Assistance? Contact the RAPS Solutions Center at +1 301 770 2920, ext. 200.


Register