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Showing 3541–3550 of 9058 articles for “Art. CE 24-11-2017 n° 396209”
…pril 2017 and persons admitted to a health or social establishment for purposes other than performance studies may be asked to take part in performance studies which do not involve any risk or constra…
…ial security scheme or who are beneficiaries of such a scheme may be asked to take part in performance studies which do not involve any risk or constraint and in which all the procedures are carried o…
…rliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, sh…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
I.-Natural persons guilty of the offence referred to in article L. 1126-20 shall also be liable to the following penalties: 1° Disqualification from civic, civil and family rights, in accordance with…
…7/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the project for the opinion of a personal data protection committ…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
…he favourable opinion of a committee for the protection of individuals and, in the case of performance studies mentioned in the second to fifth paragraphs of II of Article L. 1126-1, the authorisation…
Once the Committee for the Protection of Individuals has issued a favourable opinion and the performance study has been authorised, where applicable, by the Agence nationale de sécurité du médicament…
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