Download: Alliance for Regenerative Medicine on regulatory issues and commercialization
Michael Werner, Founder of the Alliance for Regenerative Medicine, presented at last year’s Stem Cells USA & Regenerative Medicine Congress on the topic, ‘ARM update: regulatory issues affecting commercialization.’
Download the presentation slides here.
In his presentation, Michael gives an overview on:
- Cell potency assay standards
- Use of appropriate animal models
- Improved communication between sponsors and the FDA
- Patient involvement in the approval process
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