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2023 Combo Products Summit Agenda

session

Use Of Emerging Digital Health Technologies For Combination Products

November 29, 2023 @ 3:45 pm

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4:45 pm

Moderators

Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie

Speakers

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie

MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA

Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Digital health technologies (DHT) are increasingly deployed by combination product and medicine manufacturers for a range of uses in clinical programs and medicine development. Areas such as remote patient monitoring, digital endpoints, and use of artificial intelligence and machine learning (AI/ML) in medicine discovery and development are helping to provide patients with new technologies faster and with less burden both in clinical and commercial phases. In recent years, health authorities have begun to establish early frameworks for how they will oversee and assess these technologies. We will cover recent health authority guidance for digital health technologies and explore applicability to combination product and medicine 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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