Translation of "utilise advanced clinical practice " (English → French) :

the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;

This joint action should capitalise on the research and innovation projects listed below, foster their implementation in clinical practice, and make use of their results and outcomes: ‘Clinical decision making and outcome in routine care for people with severe mental illness’ (CEDAR) (34), ‘Children of Prisoners, Interventions Mitigations to Strengthen Mental Health’ (COPING) (35), ‘European Network of Bipolar Research Expert Centres’ (ENBREC), ‘Prevalence, 1-year incidence and symptom severity of mental disorders in the elderly: Relationship to impairment, functioning (ICF) and service ...[+++]utilisation’ (MentDis_ICF65+) (36), ‘Financing systems’ effects on the Quality of Mental health care in Europe’ (REFINEMENT), ‘A Roadmap for Mental Health Research in Europe’ (ROAMER), ‘Save Young Lives in Europe: Promote health through prevention of risk-taking and self-destructive behaviours’ (SEYLE) (37), ‘Tailored implementation for chronic diseases’ (TICD) and ‘Work Together to Stop Truancy Among Youth’ (WE-STAY).

Clinical trials on advanced therapy medicinal products should be conducted in accordance with the overarching principles and the ethical requirements laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use .

(15) Clinical trials on advanced therapy medicinal products should be conducted in accordance with the overarching principles and the ethical requirements laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

3. The Commission shall draw up detailed guidelines on clinical trial authorization procedures and good clinical practice specific to advanced therapy medicinal and in particular tissue engineered products.

The Commission draws up detailed guidelines on good clinical and manufacturing practice specific to advanced therapy medicinal products.