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Hot Topics in Quality and Regulatory Affairs for Combination Products
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
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 Objective : 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.
Speaker(s)
FDA Update
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
Industry Perspective
James Wabby, MHS
AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
Industry Perspective
Jim Kershner, MSc
Eli Lilly and Company, United States
Human Factors Engineering Technical Lead
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