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.
Published on: Nov 26, 2019
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presentation by
Clara Desvignes
Director, Drugs, Medical Devices & Microbiome-based Products
Clara helps businesses create and construct global regulatory strategies for the development, assessment, and marketing of microbiome-based health products. Clara’s transversal experience includes the strategic positioning of complex and borderline health products. She builds adapted development plans, prepares and participates in agencies consultations, and helps develop regulatory submissions to support marketing authorizations for therapeutic products in the EU and in the US. Clara's regulatory expertise in microbiome products covers biologics, Live Biotherapeutic Products, medical devices, combination products, and food products.
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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