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Evaluation ViewAttendees 38

Devices (includes Medical Devices and In Vitro Diagnostics)

Drug-Device Combination Products: The Why Behind the Regulatory Strategy

Thursday, October 5, 2023
8:00 AM - 9:15 AM EDT
Location/Room: 510B
Important considerations for regulatory submissions in the US and EU when a drug-device combination integral product is co-packaged or cross-labelled/referenced with one or more devices.

Learning Objectives:

  • Key strategies for medical device companies to consider.
  • Key information for pharma companies to consider providing.
  • Tips for preparing robust regulatory submissions to health authorities.