Technical University of Denmark 1989
Eva Gamwell Henriksen is part of the IWAC Regulatory Development Team.
Eva has extensive experience from working with regulatory strategies, drug development, and strategic lifecycle management. Her area of expertise include:
- Development and adaptation of a Regulatory Strategy (development strategy, submission strategy, response strategy) from early development through first in human dose to life cycle management covering US, EU, CA, CH and Japan,
- Identification of associated regulatory risks and opportunities including how to address potential label claims during the development process, as well as the implementation of Agency interactions.
- Agency interactions – preparation support, briefing documents, rehearsals, meeting attendance, and health authority liaison
- Regulatory submissions – Management of Orphan Drug Applications, Paediatric Plans, Clinical trial Applications/INDs, MAA, NDA, BLA, renewals, extensions, and variations/supplements.
For more information about Regulatory Development click here.