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Showing 1051–1060 of 9202 articles for “Art. Commission européenne M.5449”
I.-As an exception to the provisions of Article 3 of Decree No. 2012-1246 of 7 November 2012 on public budgetary and accounting management, the Committees for the Protection of Individuals are subject…
The committees for the protection of individuals comprise thirty-six members divided into two colleges, each with 18 members: 1° The first college is made up of at least: a) Eight people with qualific…
The Chairman of the Personal Data Protection Committee is the authorising officer for expenditure and revenue.
The members elect the Chairman of the Committee from among their number by an absolute majority of those present. If this majority is not achieved after two ballots, the Chairman is elected by relativ…
Each committee has its headquarters in a public establishment with whose legal representative the Director General of the Regional Health Agency and the Data Protection Committee enter into an agreeme…
I.-An information system for research involving the human person enables: 1° Exchanges between sponsors and committees for the protection of individuals. To this end, it receives requests for advice f…
For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.
The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the…
The investigator notifies the sponsor without delay from the day on which he becomes aware of all serious adverse events and all adverse reactions and serious incidents occurring in the course of rese…
For research involving medicinal products, the Director General of the Agence nationale de sécurité du médicament et des produits de santé ensures that all suspected serious unexpected adverse reactio…
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