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Global Labeling Conference

Session 7: Combination Products and Medical Device Labeling

    Session Chair(s)
      Su-Yueh  Lin, MS, RPh

      Su-Yueh Lin, MS, RPh

      • Regulatory Labeling Consultant
      • Independent Consultant, United States
    The labeling for drug-device combination products - drugs that are combined with device-based delivery systems - continues to evolve as a topic of interest for the industry. This session will discuss the current guidance and regulations for combination product labeling in the US and EU. Useful information on combination product labeling development from conceptualization to agency approval will be provided from industry and regulator perspectives. The regulatory experience for a recently FDA-approved combination product involving mobile app will also be presented.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the latest information regarding the current regulations and guidance for combination product labeling in US and EU
    • Identify best practices when developing labeling for a drug-device combination product
    • Gain latest knowledge on the technology and regulatory pathway for incorporating mobile app in a combination product
      Ryan  McGowan

      Current Regulations and Guidance and a Process Overview for Developing the Labeling for a Drug-Device Combination Product

      Ryan McGowan

      • Associate Director, Combination Products
      • AstraZeneca, United States
      James  Meehan

      Human Factors and Labeling/IFU Development

      James Meehan

      • Associate Principal Scientist – Human Factors
      • AstraZeneca, United Kingdom
      Michael  Fahmy, MS

      Case Study: Regulatory Experience for a Drug-Device Combination Product Involving a Mobile App

      Michael Fahmy, MS

      • Director, Global Labeling Strategy & Regulatory Affairs
      • Otsuka Pharmacutical Development & Commercialization, Inc., United States