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Showing 3331–3340 of 32301 articles for “Art. 9 May 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…
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
Carrying out or causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L.…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…
…initially agreed to take part in the performance study. If the promoter is not liable, the victims may be compensated under the conditions set out in article L. 1142-3. 1142-3. All performance studie…
…e methodology of the performance study with regard to the provisions of law no. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, the need to collect and pro…
Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in adv…
…dures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable…
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