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2024 Combo Products Summit Agenda

session

Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)

October 9, 2024 @ 3:50 pm

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4:50 pm

Moderators

Bonnie OdomPartner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Chin-Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech/Roche

Speakers

Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health,(CDRH), FDA (Invited)
Shruti Mistry, Assistant Director, Injection Devices Team, Center for Devices and Radiological Health (CDRH), FDA
Renato Ravanello, Senior Director, Device Development, Genentech
Nathalie Vandenkoornhuyse, Executive Vice President, Regulatory Affairs, Coherus

ISO 11608-6 describes the requirements and test methods for on-body delivery systems (OBDS). Through a comprehensive case study, we examine critical aspects of on-body injection system design verification, such as drop test requirements, the balance between essential performance requirements and primary functions, and invaluable lessons learned. Additionally, we provide insights into regulator perspectives, highlighting common issues observed and offering key recommendations for industry professionals. The audience will be able to learn firsthand from the industry experts and regulators to ensure successful development and commercialization of OBDS for patients.

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