Traduction de «Design evaluation techniques in music therapy » (Anglais → Français) :

2. Where there is particular cause for concern, the Commission shall, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing autho ...[+++]risation and submitted for review to the Agency.

2. Where there is particular cause for concern, the Commission shall, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the m ...[+++]arketing authorisation and submitted for review to the Agency.

For this reason, they stressed the need for properly designed, randomized and controlled clinical trials to evaluate the spectrum of therapies.

The assessment of the efficacy and safety of an advanced therapy medicinal product must include the careful description and evaluation of the therapeutic procedure as a whole, including special ways of administration, (such as transfection of cells ex vivo, in vitro manipulation, or use of interventional techniques), and testing of the possible associated regimens (including immuno-suppressive, antiviral, cytotoxic treatment).

clinical trials on medicinal products intended for adults and on medicinal products intended for paediatric use, including at least one stage III clinical trial in which the new medicinal product is compared with previously authorised medicinal products used to treat the same or a similar condition in order to demonstrate the greater efficacy of the new medicinal product ; stage II and III clinical trials shall include a statistically sufficient number of women of all age groups concerned if the medicinal product is to be used to treat female patients; women-specific diseases and therapies shall be taken into ...[+++] account when designing the studies. The trials shall evaluate whether the medicinal product is efficacious for the respective indications, whether it is tolerated by women of all age groups, the appropriate dosage and its contra-indications and side-effects ,

The exhibition does not go into detail but aims to evoke the overall picture by broad brush strokes, relying largely on stage design techniques, lighting effects and music.