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Ask the experts: EU regulatory framework for microbiome product development

Post thumbnail Ask the experts: EU regulatory framework for microbiome product development

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

 

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    Featured Speakers

    Clara Desvignes, MSc thumbnail
    Clara Desvignes, MSc
    Senior Regulatory Scientist – Advanced Health Technologies
    As a Senior Regulatory Scientist, Clara supports companies in the development and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices & drugs (incl. biological medicinal products and microbiome related products), as well as combination products.
    Peri Aghadiuno, MBBS, MRCOG
    Medical Director
    As a Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a variety of…
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