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Showing 2201–2210 of 21043 articles for “Art. Cass. com. 13 April 2022”
…rry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to compl…
This sub-section applies to post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patie…
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
…of II of article L. 5126-7, of II of article L. 5141-10, of the last paragraph of article L. 5141-13-1, of the fourth paragraph of article L. 5143-2, of II of article L. 5146-1 and of II of article…
…2 to 6 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. Where the clinical investigation concerns the field of maieutics, the investigator may e…
…l as the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on th…
Clinical investigations may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of…
…ts observations. The proceeds of the repayment are collected by the bodies mentioned in article L. 213-1 of the same code, designated by the Director of the Agence Centrale des Organismes de Sécurité…
I.-The Data Protection Committee gives its opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the prote…
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