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2024 Combo Products Summit Workshop

session

Digital Health Technologies and Combination Products Sessions

October 8, 2024 @ 9:00 am

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12:00 pm

Moderators

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie

Chin Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech

Speakers

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVIE
Anchal Choudhuri, Senior Consultant, Biologics Consulting
Erez Kaminski, CEO & Founder Ketryx
Elizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epistein, Becker and Green
Eric Staib, Vice President, Corporate Quality, Syneos Health
Brandi Stockton, Managing Partner, Triality Group
Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Digital Health Technologies are increasingly used in the development, manufacturing, investigation, marketing, and maintenance of combination products. This focused session will cover a range of digital health topics that are relevant to development, quality, regulatory, and patient safety functions that support combination products.

Intro: Future of Digital Health

Session 1: Digital Health Technologies for Remote Data Acquisition

Session 2: Artificial Intelligence and Machine Learning

Session 3: Mobile Medical Device Applications

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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© 2024 AFDO/RAPS Healthcare Products Collaborative