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2024 Combo Products Summit Agenda

session

Navigating Use-Related Risk Analysis (URRA) and Comparative Analysis in the Human Factors (HF) Process

October 10, 2024 @ 10:35 am

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11:20 am

Moderators

Susan Neadle, Principal Consultant & President, Combination Products Consulting

Speakers

Patricia Love, Deputy Director, Office Of Combination Products, FDA
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

When developing your technical and regulatory strategies for combination products, a key element is building the appropriate level of content and analysis from a Human Factors perspective.  If this content is inappropriately scoped, submission timelines could be significantly impacted, potentially triggering substantial additional technical activities, meetings and review cycles.  FDA Draft Guidance “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products” (July 2024) is intended to clarify how URRA and related content can ensure the scope of Human Factors (HF) work is appropriately scoped.  In this session, FDA and industry will discuss case studies and key strategies to ensure technical and regulatory success.

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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