Traduction de «Therapy aide » (Anglais → Français) :

Gambro is a Swedish medical technology company, active globally, which develops, manufactures and supplies products and therapies for haemodialysis (HD), continuous renal replacement therapy (CRRT), liver dialysis, myeloma kidney therapy, related water systems and other extracorporeal therapies for chronic and acute patients.

The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue engineering, medical devices, pharmacovigilance and ethics.

For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics.

A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market; A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMEA), to assess advanced therapy products and follow scientific developments in the field; Tailored technical requirements, which are adapted to the particular scientific characteristics of these products; Detailed guidance for the application of good manufacturing practice and good clinical practice to advanced therapies; Strengthened requirements for risk management and po ...[+++]st-authorisation traceability; A system of low-cost, top-quality scientific advice for the industry, provided by the European Medicines Agency; Financial and administrative incentives for small and medium-sized enterprises developing advanced therapies.

This is particularly important in the context of the emergence of new therapies, such as gene therapy and associated cell therapies, and xenogenic somatic therapy.

This procedure, now compulsory for high-technology medicinal products (gene therapy and associated cell therapies, xenogenic therapies) in order to maintain the high level of scientific evaluation and thus to preserve the confidence of medical professionals and patients, will also become compulsory for orphan medicinal products; for products containing a new active substance and indicated for the treatment acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes and, four years after the entry into force of ...[+++] the Regulation, also for the treatment of auto-immune diseases, immune dysfunctions and viral diseases.