Microbiome-based products, such as Live Biotherapeutic Products (LBPs) are very innovative, therefore associated with many challenges. Navigating the complex regulatory pathway is one of these major considerations. They can fall under several regulatory statuses, in both the food and medical arenas. Their intended use, target population, presentation form, composition, mode of action and route of administration will be key in determining the corresponding status.
In this “Ask the Experts” session, our experts answered questions related to microbiome product development within the European regulatory framework, from early product positioning, clinical development to regulatory implementation, such as:
- Which agencies are more experienced with development of LBPs?
- Are there any regulatory limitations to incorporate bacteria in a medical device cream?
- Which end points can be used to evaluate the impact of a product on patients’ microbiome?
Download: Answers to the key questions
Published on: Dec 3, 2021
Access the full webinar replay now
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Featured Speakers
Clara Desvignes, MSc
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.
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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