|Early Bird ends 15 May
||After May 15
* Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
Part 1: Tuesday, 18 Jun from 12:00–2:30 pm Eastern
Part 2: Thursday, 20 Jun from 12:00–2:00 pm Eastern
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.
- 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.