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Workshop: Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions

Wednesday, November 12, 2025
12:30 PM - 3:00 PM East Coast USA Time

    Moderator(s)

  • Rumi Young

    Director, Regulatory Policy
    Novo Nordisk

  • Tine Schroder-Albeck

    Associate Director - Head of Device Development and Support
    ALK A/S

  • Ryan Hoshi

    Director, Regulatory Policy and Intelligence
    AbbVie, Inc.

    • Speaker(s)

  • Alexis Boaz

    Health Care and Life Sciences Attorney
    Epstein Becker Green

  • Katie Chowdhury

    Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products
    AbbVie, Inc

  • MK

    Margaret Kober

    Chief, Project Management Staff, Office of Regulatory Operations, Office of New Drugs, Office of New Drugs, Center for Drug Evaluation and Research (CDER)
    FDA

  • Harshit Thakkar

    Technical Director, Medical Devices Certification
    DEKRA Certification B.V.

This interactive and collaborative workshop aims to identify and address common mistakes and challenges faced by sponsors, regulators, and conformity assessment bodies (e.g., Notified Bodies) in combination product submissions. It will include a discussion on best practices and lessons learned for optimizing communication and engagement between sponsors and regulatory bodies, engagement pathways, responding to deficiencies and information requests, and pitfalls in structuring and organizing complex regulatory submissions. Such considerations may include the use of third-party drug delivery systems and leveraging platform drug delivery technologies.

Feedback from this workshop will aid in developing a best practices discussion paper on combination product submissions, which will serve as a resource guide for stakeholders.