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Advertising and Promotion Regulatory Affairs Conference


Speakers

  • Micheline  Awad, MBA

    Micheline Awad, MBA

    • Director Regulatory Affairs, Advertising and Promotion
    • Neurocrine Biosciences, Inc., United States

    Micheline Awad leads the Neurocrine Biosciences Promotional Review Committee (PRC) as well as represents Regulatory on the Medical Review Committee (MRC). She has over 17 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 11 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for 2 years. Micheline’s Regulatory experience includes Biologic, Drug, and Device, and multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing Biotechnology from George Mason University.

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Head of Regulatory Policy & Intelligence, Regulatory Affairs
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is the Head of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals (MNK) assessing changes in the regulatory environment and applicability to the MNK portfolio and activities. Prior to Mallinckrodt, Kim was an Executive director at OneSource Regulatory responsible for AdPromo regulatory review and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals (formally Bausch + Lomb). Kim has diverse experience in medical products including Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim has more than 28 years of pharmaceutical experience, including 18 years in regulatory.

  • Kellie B. Combs, JD

    Kellie B. Combs, JD

    • Partner
    • Ropes & Gray LLP, United States

    Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She serves as co-counsel to the Medical Information Working Group, represented Pacira in its litigation against FDA, and has extensive experience handling matters implicating FDA promotional rules and the First Amendment.

  • Joanne  Curley, MBA

    Joanne Curley, MBA

    • Vice President, Head of Global Regulatory Affairs
    • Jazz Pharmaceuticals, Inc., United States

    I am the head of Global Promotional Regulatory Affairs and Labeling team at Jazz Pharmaceuticals. With a bachelor’s of pharmacy from the Philadelphia College of Pharmacy and Sciences and an M.B.A. from St. Joseph’s University in Philadelphia, I have held various roles of increasing responsibility in the pharmaceutical industry over the last 23 years, including roles in operations, marketing and regulatory affairs. In my current role at Jazz, I have oversight for the regulatory labeling function globally as well as the promotional material review process for both the United States and EU/ROW.

  • Hadley H Le, PharmD

    Hadley H Le, PharmD

    • Associate Director, Medical Affairs
    • Neurocrine Biosciences, Inc., United States

  • Kevin  Stark, MBA

    Kevin Stark, MBA

    • Director, Office of Promotion and Advertising Review, Regulatory Affairs
    • Merck & Company Inc., United States

  • Eileen  Valenta, MBA

    Eileen Valenta, MBA

    • President
    • Valenta Consulting , United States

    Eileen has over 25 years of experience in global regulatory affairs including deep expertise in advertising and promotion, compliance and strategic labeling initiatives for drugs, devices, and biopharmaceuticals. Eileen has served in senior leadership roles in multiple pharma companies where she has been responsible for process and system development for creating and optimizing promotional review and integrated launch programs.

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On-Demand Complimantary Webinar

Navigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange


Call for Professional Showcase

Guidelines | Submit
Deadline: December 14