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Session 8 Track C: Essential Performance Requirements
Session Chair(s)
Suzette Roan, JD, MS
Senior Director, GRA Device Combination Products
Sanofi, United States
Essential performance requirements (EPRs) have become a key area of focus for the review of regulatory submissions for delivery system combination products over the past few years. This session will provide participants with an opportunity to gain a contemporary understanding of the FDA expectations for EPRs throughout the product lifecycle, as well as hear from Industry. Industry speakers will provide perspectives on the similarities and differences between EPRs and other regulatory expectations, such as 510(k) special controls and critical quality attributes, as well as share experiences on the practical impacts on the manufacturer related to implementing EPRs and control strategies during the review of an application.
Learning Objective : At the conclusion of this session, participants should be able to:- Define Essential Performance Requirements for combination products
- Understand the expectations for EPRs to support their combination product development and control strategies
- Gain perspectives related to the impacts of implementing EPRs late in development to inform internal strategies to address EPRs early in development
Speaker(s)
Regulatory Expectations for Essential Performance Requirements
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human
Industry Perspectives on Combination Products Essential Performance Requirements
Krystin Meidell
Biogen, United States
Manager, Regulatory Affairs CMC Combination Products and Medical
Impacts of Implementing Essential Performance Requirements and Control Strategies on Combination Product Manufacturers
John Towns, PhD
Eli Lilly and Company, United States