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Showing 1401–1410 of 3763 articles for “Art. 18 oct. 2017”
…l apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
…obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, after he has been given the…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
…dures applicable to the coordinated assessment procedure described in Article 78 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable…
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
…causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L. 1126-6, is pun…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…
The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not att…
Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in adv…
The performance study does not give rise to any direct or indirect financial compensation for the persons taking part, apart from the reimbursement of expenses incurred and, where applicable, compensa…
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