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Wednesday, June 26 • 10:30am - 11:30am
#339: Hot Topics in Quality and Regulatory Affairs for Combination Products

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-670-L04-P; CME 1.00; IACET 1.00; RN 1.00

Combination products are a hot topic in healthcare. These products combine two areas of medicine: medical devices and drugs/biologics. While these products open doors to exciting new possibilities in the medical world, they also bring new challenges.

This session will discuss the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cGXPs and Quality System regulations are enforced throughout the franchise. Open discussions, case studies and dialogue will be included.

Learning Objectives

Discuss clinical trial to launch including regulatory expectations and differences for devices and drugs, how to manage parallel development programs and minimize risks for regulatory submissions; Outline best practice of handling adverse effects, usability concerns and complaints throughout drug/ device lifecycle; Describe how to establish an on-going and rigorous post-market surveillance strategy to identify product, design, and process improvement.


Rachel SW Turow, JD, MPH


FDA Update
Melissa B. Burns, MS

Industry Perspective
James Wabby, MHS

Industry Perspective
Jim Kershner, MSc


Melissa Burns

Senior Program Manager, Office of Combination Products, FDA
Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures... Read More →
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, Abbvie, United States
James Wabby is the Executive Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
avatar for Jim Kershner

Jim Kershner

Human Factors Engineering Technical Lead, Eli Lilly and Company
Jim Kershner is a senior technical lead in the Human Factors group at Eli Lilly and Company. In this role, Jim was responsible for establishing the HF group at Lilly, and continues to drive human factors technical input in accordance with regulatory guidance, consensus standards... Read More →

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   10: RegCMC-Product Quality, Session