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Overview of EU Regulatory Landscape for Regenerative Medicines

Post thumbnail Overview of EU Regulatory Landscape for Regenerative Medicines

Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing or regenerating cells, tissues or organs in Human. In Europe, they are governed by the ATMP regulation, which entered into force in 2007.

This short presentation introduces the regulatory landscape for regenerative medicines in Europe, and discuss the main features that have been implemented. Three incentives implemented by the European Medicines Agency (EMA) for developers of regenerative medicines are also detailed.

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    presentation by

    Emmanuelle Sabbah-Petrover
    Emmanuelle Sabbah-Petrover, PhD
    Director, Complex Biologics
    As Director at Voisin Consulting Life Sciences, Emmanuelle manages projects involving cellular and gene-based medicinal products; from early stages of…
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