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Showing 2201–2210 of 68785 articles for “Art. II and III”
…tive of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in the case of research mentioned in 1° of Article L. 1121-1, authorisation from the competent…
…protection of individuals, in particular the protection of participants ;the adequacy, completeness and intelligibility of the written information to be provided, as well as the procedure to be follow…
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…
The Minister for Health may withdraw the approval of a committee if the conditions of independence, composition or operation required to carry out its mission in the best possible conditions are no lo…
…ional Commission for Research Involving the Human Person, responsible for coordinating, harmonising and evaluating the practices of the Committees for the Protection of Individuals, has been set up un…
…ves its opinion on the conditions for the validity of the research with regard to article L. 1121-2 and I of article L. 1123-7.
…sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products). II-The Agency makes its decision with regard to the safety of persons who take…
…ted regulation adopted pursuant to Article 12(8) of Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014.
The Autorité de contrôle prudentiel et de résolution may oppose the proposed acquisition only if there are reasonable grounds for doing so based solely on the criteria set out in Article R. 532-8-1, o…
…orité de contrôle prudentiel et de résolution shall assess the suitability of the proposed acquirer and the financial soundness of the proposed acquisition, applying all of the following criteria, in…
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