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Showing 5061–5070 of 10478 articles for “Art. 150 VI”
I.-The Director General of the Agency may ask the regional pharmacovigilance centres to carry out any pharmacovigilance investigations and work.He may also ask the drug dependence and addictovigilance…
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.…
…performance study. This action is time-barred under the conditions set out inarticle 2226 of the Civil Code.
…who had 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 performanc…
…ons for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the protection of participants; -the adequacy, completeness and comprehensibi…
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…
…or purposes other than performance studies. Persons likely to take part in performance studies involving an intervention on the person that is not justified by his or her usual care and which exposes…
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d'Etat and in particular: 1° The procedures applicable to the coordinated assessment procedure d…
Performance studies relating to dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Performance studies relating to midwi…
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