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Master Thesis

Délais de mise en place des essais cliniques : impacts des évolutions règlementaires et mesures déployées pour renforcer la compétitivité de la France

Abstract : Clinical trials are a key public health challenge and are evolving in an international increasingly competitive environment. France, which was perceived attractive in the early 2000s thanks to the simplicity of its administrative procedures, has for the past few years been weakened by the increase of clinical trials setup times. At a time when optimizing development time of a medicine became a priority for pharmaceutical companies, the ability to start a clinical trial quickly is an essential criterion to determine which countries will participate to the clinical development of a medicine. Start-up of a clinical trial is determined by regulatory approvals and contractualization between sponsor and health institutions participating in the research. In order to improve the France’s attractiveness, the Government adopted laws to optimize administrative procedures while maintaining patients’ safety : implementation of reference methodologies for personal data processing, adoption of the « unique contract » and adoption of a law to adapt the random selection of ethics committees. In addition, to anticipate the entry into force of the European Regulation n°536/2014 scheduled for the third quarter of 2020, the French Health Authority, ethics committees and sponsors adapt their working approach and improve communication during administrative assessment. All these measures aim to make France a partner of choice to conduct international clinical trials.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02292720
Contributor : Jean-Hugues Morneau <>
Submitted on : Friday, September 20, 2019 - 10:24:17 AM
Last modification on : Wednesday, July 15, 2020 - 8:56:03 AM
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  • HAL Id : dumas-02292720, version 1

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Pauline Jacquet. Délais de mise en place des essais cliniques : impacts des évolutions règlementaires et mesures déployées pour renforcer la compétitivité de la France. Sciences pharmaceutiques. 2019. ⟨dumas-02292720⟩

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