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Workshop: Hot Topics for Combination Products

Wednesday, November 12, 2025
8:45 AM - 11:30 AM East Coast USA Time
Location: Narragansett Ballroom

    Moderator(s)

  • Jason Lipman

    Senior Director, Global Regulatory Affairs, Devices and Combination Products
    Sanofi

    View Slides

  • Hemal Mehta

    Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products
    Johnson & Johnson

    • Speaker(s)

  • Tanner Barnes

    Associate Director - Global Regulatory Device Lead , Global Regulatory Affairs, Devices and Combination Products
    Novo Nordisk

  • Nish Gupta

    Regulatory Group Director, Devices and Combination Products
    Genentech, California, United States

  • Willy Liou

    Director of Regulatory Affairs
    Amgen

  • Amanda Matthews

    Executive Director, Head of GRS Combination Products and Medical Devices
    Pfizer

  • John McMichael (he/him/his)

    Director, CMC Regulatory Affairs, Devices & Digital Therapeutics
    AstraZeneca

  • Andrea Redd

    Associate Vice President, Global Regulatory Affairs, Drug Delivery and Combination Products
    Eli Lilly

  • Alexander Valenca

    Director, Global Regulatory Affairs, Devices and Combination Products
    Sanofi

Back by popular demand! Come join in the fun and engage with a panel of combination product regulatory experts from across industry as they share approaches, strategies, and case studies on key regulatory topics. This will be a lively, interactive, and collaborative session. The discussion will target a range of topics including CP development and submission strategy from clinical to post-market, including strategies and approaches related to clinical studies, clinical bridging, phase appropriate testing, human factors, post-approval changes, control strategies, and more.