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Showing 5821–5830 of 18177 articles for “Art. 5 oct. 2017”
I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the prot…
…rformance studies falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
…are pursuant to Chapters II to IV of Title I of Book II of Part Three of this Code or Article 706-135 of the Code of Criminal Procedure and persons admitted to a health and social establishment for pu…
…dures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable…
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
…ng conditions: 1° In vitro diagnostic medical devices included on the list mentioned inarticle L. 165-1 of the Social Security Code or covered by the list of acts and services mentioned in article L.…
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…
…icles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article 60 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a hea…
Persons who are not affiliated to a social 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…
…to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, shall also apply to performance studies.
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