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Showing 421–430 of 39773 articles for “Art. R. 145-5”
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…
…nvolving the human person, the sponsor must report the events or effects mentioned in 7° of Article R. 1123-46 to the Agence nationale de sécurité du médicament et des produits de santé without delay.…
…ommittee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the measures taken. The sponsor shall inform the Director Gene…
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…
…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 Agence n…
…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 of t…
For the research mentioned in 1° of Article L. 1121-1 other than that mentioned in Articles R. 1123-54 to R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpecte…
For the research mentioned in 1° of Article L. 1121-1 concerning cosmetic products or tattooing products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de…
In the absence of an agreement or a convention mentioned in article L. 3142-65, the employee informs the employer by any means giving a date certain, at least fifteen days before the start of the repr…
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