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Session 5B: Intravaginal-Ring and Intrauterine-System Product Development and Quality Considerations
Session Chair(s)
Yan Wang, PhD
Acting Team Lead, Division of Therapeutic Performance, ORS, OGD, CDER
FDA, United States
Robert Berendt, PhD
Branch Chief, Division of Immediate & Modified Release Products III, OLDP, OPQ,
FDA, United States
This session will continue the conversation of Intravaginal-Ring and Intrauterine Systems
Speaker(s)
Manufacturing Quality Considerations for IVRs and IUSs
Yubing Tang, PhD
FDA, United States
Chemist, CDER
Device Mechanical Testing and Compatibility Considerations for IVRs and IUSs
Monica Garcia, PhD
FDA, United States
Acting Assistant Director, Division of Reproductive, Gynecology, and Urology
Intravaginal-Ring Product Development and Quality Considerations
Brendan C Muldoon, PhD
Teva Pharmaceuticals, Ireland
Senior Director, Generics R&D
Panel Discussion
All Session Speakers, United States
Panelist
Karyn L. Berry, MD, MPH
FDA, United States
Medical Officer, Division of Clinical Review, Office of Bioequivalence, OGD
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