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Navigating the Regulatory Landscape of Drug-Device Combination Products
Session Chair(s)
Rebecca Lipsitz, PhD
Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
AstraZeneca, 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.
Speaker(s)
FDA Perspective
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Industry Perspective
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
Industry Perspective
Demetra Macheras, MBA
AbbVie, United States
Director, Regulatory Policy and Intelligence - Regulatory Affairs
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