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Bethesda North Marriott Hotel and Conference Center

2018 年 03 月 08 日 7:00 上午 - 2018 年 03 月 09 日 3:00 下午

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

Advertising and Promotion Regulatory Affairs Conference

Session 11 Track B: 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 : Upon completion 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
  • Understand the various roles and responsibilities within OPDP and APLB to enhance appropriate interactions and touch points

Speaker(s)

Jean-Ah  Kang, PharmD

Panelist

Jean-Ah Kang, PharmD

FDA, United States

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

Leah  Palmer, PharmD

Panelist

Leah Palmer, PharmD

United States

Consultant, Regulatory Promotion

Sheetal  Patel, PharmD

Panelist

Sheetal Patel, PharmD

Johnson & Johnson, United States

Vice President, Specialty Compliance

Lisa  Stockbridge, PhD

Panelist

Lisa Stockbridge, PhD

FDA, United States

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

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