Article L1125-26
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
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Showing 4701–4710 of 55685 articles for “Art. Cass. soc. 5 November 1987 · Cass. soc. 2 April 1998 · Cass. soc. 2 July 1981 · Cass. soc. 5 November 2009 · Cass. soc. 29 June 2017 · Cass. soc. 28 September 2010 · Cass. soc. 24 October 1989 · CA Paris 16 December 2009”
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical inv…
Performing or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
…decide on the merger within twenty-five working days from the date of receipt of the complete notification. II. - The parties to the transaction may undertake to take measures designed in particular t…
The amounts provided for in articles R. 332-54 and R. 332-55 are calculated net of the value of guarantees received under an eligible master agreement. An eligible master agreement meets all of the fo…
This Title, with the exception of article R. 355-34, is applicable in New Caledonia, the overseas territories and Mayotte, subject to the following adaptations: 1° In articles R. 355-33 and R. 355-38,…
Given the requirements of the public education service, the weekly service of staff belonging to teaching bodies or job categories who benefit from a credit of hours in accordance with article L. 7227…
…e do not comply with the requirements of this Title, and in particular those of the national specifications for approval, he may, after obtaining the opinion of the occupational health inspector: 1° I…
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