appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients associations
A Committee for Advanced Therapies shall be established within the Agency.
e.g. Committee for Advanced Therapies, Pharmacovigilance Risks Assessment Committee, Paediatric Committee
The Committee for Advanced Therapies shall evaluate the valid application within 90 days following its acknowledgment of receipt.
When the Committee for Advanced Therapies has completed its evaluation, the Agency shall inform the applicant accordingly and provide him without delay with the following documents
Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
This procedure ensures that these products are assessed by a specialized body (the Committee for Advanced Therapies, or CAT) and that the marketing authorization is valid in all the European Union Member States.
The EFTA States shall be fully associated with the work of the Committee for Advanced Therapy, but without the right to vote.
In that case, the time-limit laid down in Article 2shall be suspended until the visit report has been made available to the Committee for Advanced Therapies and to the applicant.
At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.
The Committee for Advanced Therapies shall elect its Chairman from among its members for a term of three years, renewable once.
When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members.
The Committee for Advanced Therapies, with its unique expertise, should have a prominent role in the provision of such advice.
The Committee for Advanced Therapies should gather the best available expertise on advanced therapy medicinal products in the Community.
The Committee for Advanced Therapies shall also be consulted in the event of re-examination of the opinion pursuant to Article 9(2) of Regulation (EC) No 726/2004.
In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMA), to assess advanced therapy products and follow scientific developments in the field.
Requêtes fréquentes français :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Requêtes fréquentes anglais :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Traduction Translation Traducción Übersetzung Tradução Traduzione Traducere Vertaling Tłumaczenie Mετάφραση Oversættelse Översättning Käännös Aistriúchán Traduzzjoni Prevajanje Vertimas Tõlge Preklad Fordítás Tulkojumi Превод Překlad Prijevod 翻訳 번역 翻译 Перевод