Traduction de «responsable principal des essais » (Français → Anglais) :

1. The competent authority of each Member State shall designate a central excise liaison office to which principal responsibility shall be delegated for contacts with other Member States in the field of administrative cooperation with respect to legislation on excise duties.

‘Principal investigator’ means an investigator who is the responsible leader of a team of investigators who conduct a clinical trial at a clinical trial site.

The sponsor of the clinical trial (the responsible party for the trial) provides and updates the information in the register via the national competent authority of the country, or countries, in which it is being conducted.

2. In addition to the requirements laid down in paragraph 1, the manufacturer shall submit to the technical service responsible for the type-approval test the following:

For centrally owned systems a Central Informatics Security Officer (CISO) shall be nominated.

Research will focus on: developing promising candidate interventions (vaccines, therapies and HIV microbicides) against the target diseases by sponsoring research over the full spectrum from basic molecular research, taking advantage of microbial genomics, through to pre-clinical testing and proof-of-principle; establishing a clinical trials programme to unite and support Europe's clinical trial activities specifically targeted at interventions for use in developing countries; establishing an AIDS Therapy Trials Network in Europe to improve the coherence and complementarity of clinical trials of AIDS therapies for European use.