Post-approval named patient use programs
French translation: programmes d'utilisation après approbation chez les patients désignés
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| 23:45 Sep 1, 2014 |
| English to French translations [Non-PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: FX Fraipont (X) Belgium Local time: 21:36 | ||||||
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| 4 +1 | programmes d'utilisation après approbation chez les patients désignés |
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Answers
4 hrs confidence: 
peer agreement (net): +1
peer agreement (net): +1| post-approval named patient...... programmes d'utilisation après approbation chez les patients désignés Explanation: "L'ICH9 définit les déclarations sollicitées comme étant celles provenant de systèmes organisés de collecte de données, notamment les essais cliniques, les registres, les programmes d'utilisation après approbation chez les patients désignés, d'autres programmes de soutien du patient et de prise en charge de la maladie, les enquêtes menées auprès des patients et des fournisseurs de soins de santé, ou la collecte de renseignements au sujet de l'efficacité du traitement ou de l'observance thérapeutique. Solicited reports are defined by the ICH9 as those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or health care providers, or information gathering on efficacy or patient compliance. " http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-guida... -------------------------------------------------- Note added at 12 hrs (2014-09-02 12:18:34 GMT) -------------------------------------------------- this is of course for drugs without any authorisation : http://en.wikipedia.org/wiki/Marketing_Authorization_Applica... "Another way of obtaining medicines without a marketing authorisation is on a named patient basis. In contrast to compassionate use programmes the doctor (or CoE) requests supply of the medicine directly from the manufacturer for a specific (“named”) patient under his or her direct responsibility. Manufacturers need to keep track of patients treated." Initial investigation to assess the feasibility of a coordinated ... http://ec.europa.eu/enterprise/.../access_orphans_initialinv... |
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