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Showing 2241–2250 of 61711 articles for “Art. R 330-2 · Cass. com. 7 July 2004 · CA Paris 5 November 2008”
The head of the user undertaking establishment shall rank the list of external undertakings meeting the criteria defined in Article R. 4523-6 in order of relevance. He shall mention the companies he i…
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…
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…
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…
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…
For the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge…
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