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2023 Combo Products Summit Agenda

session

Evolution Of Essential Performance Requirements

November 29, 2023 @ 1:25 pm

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2:25 pm

Moderator

Rumi Young, Director, Regulatory Policy, BD

Speakers

Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals

Subhi Saadeh, Sr. Manager – Combination Products QA, Gilead Sciences

Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices, AbbVie

For the past several years, pharmaceutical and device constituent manufacturers have encountered FDA requests for Essential Performance Requirements (EPRs) in verification testing, clinical validation, manufacturing control strategies, and bridging strategies. Despite their prevalence and perceived importance, FDA has not issued a formal definition, and ISO 11608-1 released a competing concept called Primary Function. This panel will discuss the inception of EPRs, benefits, and their relationship with Primary Function.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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