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DIA 2018 Global Annual Meeting

Navigating the Regulatory Landscape of Drug-Device Combination Products

    Session Chair(s)
      Rebecca  Lipsitz, PhD

      Rebecca Lipsitz, PhD

      • Associate Director
      • Janssen, United States
    The focus of the session will be on understanding the regulatory challenges and key success factors for development and lifecycle management of drug-device combination products in light of the evolving global regulatory requirements for these products.
    Learning Objective : Describe the changing global regulatory landscape for combination products; Discuss development approaches to meet these requirements throughout the lifecycle of the combination product; Identify the success factors that will help minimize the risk associated with these regulatory challenges, thereby reducing the likelihood of agency request for information during the review period.