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Showing 3351–3360 of 32301 articles for “Art. 9 May 2017”
…e appropriate, set a period of exclusion during which the person who is the subject of the research may not participate in any other research. The length of this period varies according to the nature…
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…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a committee for the protection of individuals and, in the case o…
…t et des produits de santé. In the event of an unfavourable opinion from the committee, the sponsor may request that its proposed substantial amendment be submitted for a second examination to another…
Any promoter whose civil liability is not covered by the insurance provided for in article L. 1126-8 shall be punished by one year's imprisonment and a fine of 15,000 euros.
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
No performance study may be carried out on a deceased person in a state of brain death without his or her consent expressed during his or her lifetime or through the testimony of his or her family. Ho…
…n the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Arti…
No performance study may be carried out on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 201…
Failure to comply with Article 73(1) and Article 76(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on the communication of information intended to be made…
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