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2023 Combo Products Summit Agenda

session

Part 1 – Bridging And Leveraging Human Factors Data In Drug-Device Combination Products Development. Part 2 – Q&A And Discussion Of Final Guidance Of Application Of HF Engineering Principles For Combination Products

November 30, 2023 @ 10:25 am

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11:40 am

Moderator

Jiaying Shen, Distinguished Scientist, Merk

Speakers

Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER), FDA

Carrie O’Donel, Principal Device Engineer, Teva Pharmaceuticals

Jen Soosaar, Director of Human Factors, Core Human Factors, Inc

Colin Roscoe, Principal Human Factors Scientist, Teva Pharmaceuticals

In recent years, we have witnessed a remarkable shift in global regulatory agencies and industries, recognizing the immense value and importance of Human Factors Engineering. This field, which focuses on understanding how people interact with products, systems, and environments, has become an integral part of ensuring the safety, effectiveness, and usability of various products and services. We have witnessed firsthand the increasing investment in this discipline. While the growth in Human Factors Engineering is undoubtedly positive, it also presents us with new challenges. With the rise in demand for efficiency and cost-effectiveness, there is a parallel need to strike a balance—a balance between conducting thorough studies and not overburdening our budgets. Part 1 of this session aims to explore the strategies for achieving effective and efficient human factors work – how to bridge and leverage human factors data in drug-led combination product development.

In September 2023, FDA issued the final guidance of Application of Human Factors Engineering Principles for Combination Products. In part 2, we will be engaging in questions and answers during this session. This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.

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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