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Showing 3061–3070 of 13796 articles for “Art. European Commission report COM”
…or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate in advance to the pharmacist managing this pharmacy the data relating to clinical invest…
The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applica…
…professional or social activity in the course of which, or in the course of which, the offence was committed; 3° disqualification from public contracts, either permanently or for a period of up to fi…
…he clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the aforeme…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
…organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulting from a clinical investigation; this action is time-barred under th…
…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 or an unfavourabl…
…arried out and the products are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary for the person not to b…
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…
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