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Whitepaper

Clinical trials with ATMPs in Europe: a focus on GMO specificities

Post thumbnail Clinical trials with ATMPs in Europe: a focus on GMO specificities

Advanced Therapy Medicinal Products (ATMPs) are an innovative type of medicines for human use, based on genes, cells or tissues. The multiplicity of clinical studies involving ATMPs and more especially GMO products has brought us to focus on the specific requirements for these type of clinical trials.
The aim of this article is to synthesize the European regulation of the ATMPs and particularly to discuss some of the European national specific procedures for clinical trials with Genetically Modified Organisms (GMOs). Because the use of GMOs in clinical trials falls under two directives in Europe, national implementation has led to a lot of differences between the European countries regarding regulatory framework, and administrative requirements for clinical trials with GMOs.

Key learning objectives :

  • Define the GMO frameworks “contained use” and “deliberate release” and understand the specific requirements resulting from it.
  • Provide an overview of the national regulatory framework in France, Germany, Italy and United Kingdom.
  • Emphasize the differences to open the discussion on the harmonization of the ATMP’s regulation among EU countries.
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    whitepaper by

    Marie Michel  thumbnail
    Marie Michel
    Senior Regulatory Scientist
    Submission and maintenance of the clinical trial application package to European competent authorities and ethics committees, for small molecules and GMOs. Coordination of a project team to ensure that all national/local requirements for the concerned countries are checked and necessary documents are drafted and reviewed in accordance with local requirements.
    Gopalan Narayanan
    Gopalan Narayanan, M.D.
    Vice President, Disruptive Biologics
    Dr. Narayanan provides leadership within the area of complex and disruptive biologics such as Cell and Gene therapies, called Advanced…
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    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…
    View profile
    Elena Gueudar Delahaye thumbnail
    Elena Gueudar Delahaye
    Regulatory Scientist, Clinical Trials Submissions and Operations
    As a Regulatory Scientist, in the Clinical Trials Submissions and Operations team Elena has responsibility for managing submission and maintenance of clinical trial applications.