What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective
- Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements;
- Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies;
- Regulatory NC considerations and approach;
- Take-home messages: integrated approach CMC / nonclinical / clinical.
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presentation by
Clara Desvignes
Senior Regulatory Scientist
As a senior regulatory scientist at VCLS, Clara is involved in the development of microbiome-related health products, both in the medical and food area. Clara earned an engineering degree majoring in Sciences and Technologies of human biology, nutrition and food, at AgroParisTech, France. She also studied specialized food products in the University of Milan, Italy, as part of her engineering’s degree. Prior to joining VCLS, and as part of her engineering degree, Clara worked for 6 months at RNI-Consulting (Angers, France), where she gained particular experience in the areas of for nutritionals and nutraceuticals
Cécile F. Rousseau, PhD
Senior Director, Nonclinical
With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices,…
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Peri Aghadiuno, MBBS, MRCOG
Senior Medical Director
As a Senior Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a…
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