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Mar 16
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08:30 - 09:00 30 mins
09:00 - 15:00 360 mins
Establishing a Regulatory Framework for Microbiome Therapeutics
  • Marielle Fournier - Senior Director, Drugs, Devices & Combination Products, Voisin Consulting Life Sciences
  • François Gianelli - Associate Director, Voisin Consulting Life Sciences
  • 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
15:00 - 15:05 5 mins
End of Post Conference Workshop