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Omni Shoreham Hotel

Feb 23, 2017 7:00 AM - Feb 24, 2017 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 9B: Building Bridges: Creating and Maintaining a Productive Relationship with FDA on Advertising and Promotion Issues

Session Chair(s)

Paul  Savidge, JD, MBA

Paul Savidge, JD, MBA

Senior Regulatory Counsel

Spark Therapeutics, Inc., United States

For US regulatory affairs professionals, the FDA is a key customer and establishing an effective, productive relationship with the agency cannot be left to chance. A solid foundation for this relationship is a keen understanding of the role and objectives of the FDA on advertising and promotion issues. With that knowledge, company regulatory professionals can begin to build and then sustain a strategic, mutually respectful relationship with FDA that can result in greater efficiency and transparency, more effective promotional materials and fewer surprises.

In this session, you will learn:

  1. What is the role of FDA (OPDP and APLB) on advertising and promotion issues and what is FDA trying to achieve?
  2. Are there significant differences between how OPDP and APLB approach their responsibilities?
  3. What do the reviewers at OPDP and APLB want from industry regulatory professionals?
  4. What is a “strategic” approach to promotional regulatory issues and what are its benefits?
  5. What are the best approaches to building a strategic relationship with FDA on advertising and promotion issues?
  6. What are the opportunities to have productive interactions with FDA?
  7. What are the best approaches to seeking advisory comments?
  8. How can you engage FDA if you have questions about advertising regulations or guidance documents?
  9. What is the significance of a “change of opinion” letter from FDA?
  10. What are best practices in responding to and resolving an FDA enforcement (warning or untitled) letter?
  11. When and how should you alert FDA if the company identifies a mistake?


Jean-Ah  Kang, PharmD


Jean-Ah Kang, PharmD

FDA, United States

Special Assistant to the Director, Office of Prescription Drug Promotion, CDER

Kristen  Heinlein, PharmD


Kristen Heinlein, PharmD

Takeda, United States

VP, US Advertising and Promotion Regulatory

Dolores  Shank-Samiec, MS


Dolores Shank-Samiec, MS

Merck, United States

Retiring as of 3/5/2021

Denise  Rieker Clark, MS


Denise Rieker Clark, MS

Sanofi Pasteur, United States

Director, Regulatory Policy

Lisa  Stockbridge, PhD


Lisa Stockbridge, PhD

FDA, United States

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER

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