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Bethesda North Marriott Hotel and Conference Center

Feb 28, 2019 7:00 AM - Mar 01, 2019 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 12: Building Bridges: Creating and Maintaining a Productive Relationship with FDA on Advertising and Promotion Issues

Session Chair(s)

Lucy  Rose, MBA

Lucy Rose, MBA

President

Lucy Rose and Associates, 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.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe examples of best practices of effective communications with OPDP and APLB
  • Identify appropriate needs and opportunities to proactively interact with OPDP and APLB
  • Discuss the various roles and responsibilities within OPDP and APLB to enhance appropriate interactions and touch points

Speaker(s)

Jean-Ah  Kang, PharmD

Panelists

Jean-Ah Kang, PharmD

FDA, United States

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

Dolores  Shank-Samiec, MS

Panelists

Dolores Shank-Samiec, MS

Merck, United States

Retiring as of 3/5/2021

Michele  Sharp, PharmD

Panelist

Michele Sharp, PharmD

Eli Lilly and Company, United States

Senior Director, Global Regulatory Affairs

Lisa  Stockbridge, PhD

Panelists

Lisa Stockbridge, PhD

FDA, United States

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

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