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
Moderator
Shannon Hoste, Chief Scientific Officer for Pathway for Patient Health
Speakers
Natalie Abts, Head of Human Factors Engineering Device and Packaging Development, Genentech
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA
Patricia Love, Deputy Director, Office of Combination Products, FDA
Jenny Wu, Associate Director, Human Factors, AstraZeneca
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 FDA Draft Guidance “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products” (July 2024) is intended to clarify how URRA and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 that the scope of Human Factors (HF) work is appropriately scoped. In this session, FDA and industry will discuss case studies and key strategies to ensuring technical and regulatory success.