The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Navigating the Regulatory Landscape of Drug-Device Combination Products
Rebecca Lipsitz, PhD
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
Associate Director, Policy and Product Classification Officer, OCP, OC
FDA, United States
Kirsten H. Paulson, MS, RAC
Senior Director, Global CMC Medical Devices
Pfizer Inc, United States
Demetra Macheras, MBA
Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, Inc., United States