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Showing 1471–1480 of 58660 articles for “Art. avis 2015-04 of 5 February 2015”
Employees who so wish may, in agreement with their employer, give up part of their rest days in return for an increase in their salary. The agreement between the employee and the employer must be in w…
In addition to the Director, who chairs it, the person in charge of human resources management and staff representatives, the Management Committee includes a representative of the region appointed by…
…itions committee, reporting to its Director, under the conditions laid down by Decree no. 2020-1427 of 20 November 2020 relating to administrative social committees in State administrations and public…
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 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…
For the research mentioned in 1° of Article L. 1121-1 involving the cell therapy preparations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament e…
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
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…
For the research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse…
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