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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, LLC, 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
      Jean-Ah  Kang, PharmD


      Jean-Ah Kang, PharmD

      • Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
      • FDA, United States
      Leah  Palmer, PharmD


      Leah Palmer, PharmD

      • Consultant, Regulatory Promotion
      • L Palmer RegPromo Consulting, LLC, United States
      Sheetal  Patel, PharmD


      Sheetal Patel, PharmD

      • Head, Regulatory Advertising and Promotion
      • Johnson & Johnson International, United States
      Lisa L. Stockbridge, PhD


      Lisa L. Stockbridge, PhD

      • Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
      • FDA, United States

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