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Tuesday, June 26 • 2:00pm - 3:15pm
#263: Navigating the Regulatory Landscape of Drug-Device Combination Products

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-598-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Rebecca Lipsitz, PhD


FDA Perspective
John Barlow Weiner, JD

Industry Perspective
Kirsten H. Paulson

Industry Perspective
Demetra Macheras, MBA

avatar for Rebecca Lipsitz

Rebecca Lipsitz

Director, Regulatory Policy, Janssen, United States
Rebecca Lipsitz is a Director in Janssen’s Global Regulatory Policy and Intelligence office. She advises and develops policy on a broad range of FDA-related regulatory issues. Her portfolio areas include Immunology, Infectious Disease, Vaccines, Precision Medicine, Combination Products... Read More →
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, Inc., United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory... Read More →
avatar for Kirsten Paulson

Kirsten Paulson

Senior Director, Global CMC Medical Devices, Pfizer Inc
Kirsten Paulson is Sr. Director, Worldwide Regulatory CMC and Medical Device Lead at Pfizer. Previously, she was the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD RA Medical Device and Diagnostics group. She began her career as an FDA reviewer... Read More →
avatar for John Weiner

John Weiner

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session