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Showing 3741–3750 of 33006 articles for “Art. CJEU – C-48/16 – 17 May 2017”
…itially agreed to take part in the clinical investigation. Where the sponsor is not liable, victims may be compensated under the conditions set out in article L. 1142-3. All clinical investigations, w…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
…n the event of a refusal of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation o…
…so, must set a period of exclusion during which the person who is the subject of the investigation may not participate in another clinical investigation. The length of this period varies according to…
No clinical investigation 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 fam…
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
…ation is unrelated to their pathological condition. However, the Personal Data Protection Committee may decide in other cases, taking into account the risks and constraints involved in the clinical in…
The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…icles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a hea…
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