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Showing 4421–4430 of 24607 articles for “Art. CA Douai 12-5-2016 n° 15/03664”
Each centre shall have an administrative social committee and, where applicable, a specialised health, safety and working conditions committee, reporting to its Director, under the conditions laid dow…
Notwithstanding article 6 of the above-mentioned decree of 20 November 2020, the social committee of each centre is created by a decision of its board of directors.
…the terms of settlement of the contract, the purchaser shall annotate the single copy or the certificate of transferability with a note recording the change.
For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.
The sponsor shall keep detailed records of all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at i…
…s defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions occurring in Fran…
…General of the Regional Health Agency without delay of any new facts involving persons with no medical condition who voluntarily lend themselves to research and, where appropriate, of the measures ta…
For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et…
…nvolving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse reaction occurring in a person undergoing such research…
…n of cell therapy preparations, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any serious adverse reaction and any serious incident occurring in F…
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