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Session 4: Combination Product Regulatory Submissions: Considerations for Product Development
Session Chair(s)
David Amor
Digital Health - QA/RA
Apple, United States
Regulatory submissions for combination products have evolved significantly in the past decade. From determination of modes of action to assessing requirements for combination product submissions, manufacturers have been forced to understand how two constituent products – with their own submission requirements – can be merged into a comprehensive regulatory filing. This session will review considerations for manufacturers in preparing combination product regulatory submissions, and will include specific case studies that illustrate key concepets.
Learning Objective :
Speaker(s)
Combination Product Regulatory Submissions: Considerations for Product Development
Kevin Bardonner
Eli Lilly and Company, United States
Research Scientist, Global Regulatory Affairs, CMC-Devices
Combination Product Regulatory Submissions: Considerations for Product Development
Sugato De
PAREXEL International, United States
Principal Consultant
Combination Product Regulatory Submissions: Considerations for Product Development
Suzette Roan, JD, MS
Sanofi, United States
Senior Director, GRA Device Combination Products
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