2024 Combo Products Summit Agenda
session
Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)
October 9, 2024 @ 10:25 am
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11:25 am
Moderators
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products, Genentech/Roche
Speakers
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.