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Showing 8131–8140 of 43699 articles for “Art. 738-2”
The committees are composed in such a way as to guarantee their independence and the diversity of their expertise in the field of research involving the human person and with regard to ethical, social…
Performing or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
Carrying out or causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L.…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…
Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in adv…
In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponso…
An order by the Minister for Health, issued on a proposal from the Agence de la biomédecine and the Haute Autorité de santé, defines the rules of good practice applicable to the prescription and perfo…
Health professionals practising on a self-employed basis, health establishments, health services and the bodies mentioned in article L. 1142-1, and any other legal entity, other than the State, carryi…
The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (…
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