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Showing 3071–3080 of 13796 articles for “Art. European Commission report COM”
…l investigation is unrelated to their pathological condition. However, the Personal Data Protection Committee may decide in other cases, taking into account the risks and constraints involved in the c…
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…
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…cision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation (EU) 2017/745 of the European Parliament and o…
…a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical investigations mentioned in the second and third paragraphs o…
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…
…vestigations which do not involve any risk or constraint. By way of derogation, the Data Protection Committee may authorise a person who is not affiliated to a social security scheme or who is a benef…
…may be carried out under the direction and supervision of a qualified person. The Data Protection Committee ensures that the qualifications of the investigator(s) match the characteristics of the cl…
…ormed 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 punishable by three…
Once the Data Protection Committee has issued a favourable opinion and the investigation has been authorised by the Agence nationale de sécurité du médicament et des produits de santé, where applicabl…
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