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Master Thesis

Attractivité de la France au regard des délais entre la réception des documents nécessaires aux soumissions des demandes initiales d’autorisations d’essais cliniques et l’ouverture du premier centre d’investigation clinique

Abstract : The aim of this thesis is to determine whether France is an attractive subsidiary regarding regulatory timelines compared to its European neighbors (Germany, Italy, Spain), from the point of view of an international pharmaceutical laboratory headquarter. This is determined here through the different timelines analysis of French subsidiary between the receipt of documents for the initial submission of a clinical trial for authorization to the health and ethics authorities and the opening of the first clinical investigation site. These timelines were compared with the theoretical deadlines described by the company French subsidiary and the ones legally described then with the deadlines of three European countries with a comparable number of clinical trials started in 2018.
Document type :
Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03428193
Contributor : Ufr Santé Unicaen Connect in order to contact the contributor
Submitted on : Monday, November 15, 2021 - 9:30:02 AM
Last modification on : Wednesday, December 1, 2021 - 3:39:53 AM

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LE GUYADER-Claire.pdf
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  • HAL Id : dumas-03428193, version 1

Citation

Claire Le Guyader. Attractivité de la France au regard des délais entre la réception des documents nécessaires aux soumissions des demandes initiales d’autorisations d’essais cliniques et l’ouverture du premier centre d’investigation clinique. Sciences pharmaceutiques. 2020. ⟨dumas-03428193⟩

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