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Session 10C: Drug/Device Combination Products
Session Chair(s)
Douglas Mead
Director, CMC Global Regulatory Affairs
Janssen Pharmaceutical Companies of Johnson&Johnson, United States
Evolving regulations and requirements related to drug/device combination products have increased the complexity of their development, including questions of their use in clinical trials, design validation, regulatory submission content, and post market changes. This session will focus on the latest changes and trends in regulatory requirements that are impacting the introduction of new drug delivery technologies. In addition to increasingly specific technical requirements, health authorities are also starting to expect that to-be-marketed presentations be used in clinical trials and that the usability of these devices be assessed in formal human factors studies. Session speakers will address the current regulatory landscape for these requirements and strategies that may successfully meet them.
Speaker(s)
FDA Updates to Combination Product Regulations
Patricia Love, MD, MBA
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
Human Factors Study Requirements For Drug/Device Combination Products
Mark Marley
Eli Lilly and Company, United States
Principal Research Scientist - Regulatory-Devices
Clinical Trial Challenges Related To Drug/Device Combination Products
Donna French, PhD
Genentech, a Member of the Roche Group, United States
Senior Director
Clinical Trial Challenges Related To Drug/Device Combination Products
Le Dao
Genentech, a Member of the Roche Group, United States
Principle Research Associate
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