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Tuesday, June 21 • 9:15am - 10:15am
#214: New Policy Developments in Combination Products

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-552-L04-P ; CME 1.00; RN 1.00

This session will engage an expert panel in discussion on a number of timely regulatory policy topics for drug-device combination products. FDA is set to issue new draft guidance on human factors and EPRs, which will impact combination product reviews. In addition, there are still a number of outstanding regulatory questions around global approaches to combination products, especially with the implementation of the MDR in Europe. This session will also focus on digital health combination products as well as the impact of the Genus decision on certain products that have historically been regulated as drugs.

Learning Objectives

Discuss recent trends and changes in the regulation and development of combination products; Describe changes in digital health regulation and regulation of contrast agents that may impact combination products; Discuss new regulatory guidance and harmonization efforts, as applicable, or opportunities for new guidance to address current challenges.

Chair

Megan Doyle, JD, MPH

Speaker

Industry Update
James Wabby, MHS

Industry Update
Susan Neadle, MS

FDA Update
John Barlow Weiner, JD

Industry Update
Chelsea O'Connell, MS, RAC

EMA Update
Christelle Bouygues



Speakers
avatar for Christelle Bouygues

Christelle Bouygues

Acting Head of Regulatory Affairs, Office Scientific and Regulatory Management, European Medicines Agency, Netherlands
Degree in Pharmacy and Regulatory Affairs. Joined the EMA in 2004 as Regulatory Affairs Adviser. She is responsible for provision of regulatory and procedural advice in relation to centralised procedures and referrals.
avatar for Susan Neadle

Susan Neadle

Principal Consultant and President, Combination Products Consulting Services LLC, United States
Susan Neadle is a recognized international Combination Products and Medical Device expert with over 30 years industry experience. Susan is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Susan’s leadership, innovation... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, Inc., United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... 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 21, 2022 9:15am - 10:15am CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session