Event Location: Amsterdam
Event Date: Friday, March 16, 2018 - 09:00 to 15:00
Workshop led by Marielle Fournier, Senior Director, Drugs, Devices & Combination Products and co-led by François Gianelli, Associate Director, CMC & Quality :
Establishing a Regulatory Framework for Microbiome Therapeutics
- What are the regulatory requirements to license a microbiome drug?
- Expectations for different microbiome treatment modalities e.g. single strain vs. consortia
- Expectations for clinical trials, CMC, quality, GMP production
- Differences between EU and USA requirements.
To meet Marielle, pleas contact us to book a meeting.