Article L1123-10
…safety, keeps a documentary record of them and notifies them to the sponsor. The notification procedures are defined by decree. It informs the sponsor of all serious adverse events occurring in parti…
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Showing 1741–1750 of 36505 articles for “Art. EU Regulation 2020/1503 du 7-10-2020”
…safety, keeps a documentary record of them and notifies them to the sponsor. The notification procedures are defined by decree. It informs the sponsor of all serious adverse events occurring in parti…
The sponsor is responsible for compensation for the harmful consequences of research involving the human person for the person who undergoes the research and for those of his successors in title, unle…
…121-1 and Article L. 1124-1, failure by the sponsor to provide investigators free of charge for the duration of the research with the investigational medicinal products and, where applicable, the devi…
…ble to the fine provided for in article 433-17 of the French Penal Code in accordance with the procedures provided for inarticle 131-38 of the same code, as well as the penalties provided for in 2° to…
…National Medical Accidents Commission is also responsible for drawing up recommendations on the conduct of expert appraisals, ensuring that this chapter is applied consistently by the regional commis…
…ssional secrecy with regard to information that may have come to their knowledge by virtue of their duties, under the conditions and subject to the penalties laid down in articles 226-13 and 226-14 of…
A decree by the Conseil d'Etat shall determine the procedures for applying the provisions of this chapter, with the exception of article L. 1321-9, and in particular those relating to the monitoring o…
When a legally practised nuclear activity becomes subject to one of the regimes mentioned in Article L. 1333-8 as a result of a change in the conditions of application of that article and without the…
The Agency is headed by a Director General, appointed by decree. The Director General issues opinions and recommendations falling within the remit of the Agency and, on behalf of the State, takes deci…
…mply with the prohibition measures mentioned in article L. 1335-4 is punishable by a fine of 15,000 euros.
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