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Showing 4461–4470 of 60498 articles for “Art. Decree 2022-1294 of 5-10-2022”
In accordance with the provisions of the first paragraph of article 362 of the present code, if the provisions of the first two paragraphs of article 132-23 of the penal code are applicable, the presi…
An individual agreement for a fixed number of days over the year may be concluded, within the limit of the number of days set in application of 3° of I of article L. 3121-64: 1° Managers who have auto…
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…
…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…
For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agenc…
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