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Showing 3751–3760 of 33006 articles for “Art. CJEU – C-48/16 – 17 May 2017”
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…
Subject to the provisions of articles L. 1123-15 to L. 1123-20, the provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of a…
…ersons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in clinical investigations which do not involve any risk or constraint. By…
Clinical investigations in the field of dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Clinical investigations in th…
…g 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. 1121-6, is pun…
…cines and Health Products). In the event of an unfavourable opinion from the committee, the sponsor may request that its substantial amendment project be submitted for a second review to another perso…
…l apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
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…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
…dures applicable to the coordinated assessment procedure described in Article 78 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable…
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