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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

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.
      John Barlow Weiner, JD

      FDA Perspective

      John Barlow Weiner, JD

      • Associate Director, Policy and Product Classification Officer, OCP, OC
      • FDA, United States
      Kirsten H. Paulson, MS, RAC

      Industry Perspective

      Kirsten H. Paulson, MS, RAC

      • Senior Director, Global CMC Medical Devices
      • Pfizer Inc, United States
      Demetra  Macheras, MBA

      Industry Perspective

      Demetra Macheras, MBA

      • Director, Regulatory Policy and Intelligence - Regulatory Affairs
      • AbbVie, Inc., United States