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Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the EU and the US
Published on: Aug 8th, 2024
Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various health issues. Innovative technologies and health products based on and/or targeting microbiome have emerged, raising unprecedented questions as part of their development. Navigating this emerging field, developers and regulators have to develop adapted approaches and regulatory frameworks for the development of microbiome health products.
In this session, we aim to guide you through the global development of your microbiome product, by answering questions such as:
- How are microbiome therapeutics regulated under the EU and US frameworks?
- What challenges will you need overcome to reach the clinic?
- How to leverage interactions with regulators in the EU and in the US to de-risk and accelerate your development?
- What recent evolutions occurred in the EU and US frameworks and guidance for Microbiome products? What can we expect for the future?
- Strategic considerations for selecting the location of initial clinical studies?
SAMPLE OF THE WEBINAR
Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the EU and the US (Teaser)
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