איפיוני התכשיר
English translation: (Summary of) Product Characteristics
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| 19:24 Jan 17, 2012 |
| Hebrew to English translations [PRO] Medical - Medical (general) / Clinical Trials | |||||||
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|  Selected response from: Ty Kendall United Kingdom Local time: 01:12 | ||||||
Grading comment
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| 5 +1 | product characteristics |
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| 5 | (Summary of) Product Characteristics |
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Answers
37 mins confidence: 
(Summary of) Product Characteristics Explanation: "A clinical study conducted within the conditions of the approved Summary of Product Characteristics or under normal conditions of use. A post-authorisation study may also be a Post-authorisation safety study (PASS)." http://www.pharmacovigilance.org.uk/tag/summary-of-product-c... Seems straightforward?, unless I'm missing something.... -------------------------------------------------- Note added at 41 mins (2012-01-17 20:05:14 GMT) -------------------------------------------------- Also.... "This should be prepared from all available information and evidence that supports the rationale for the proposed clinical trial and the safe use of the investigational medicinal product (IMP) in the trial and be presented in the format of summaries. The summary of product characteristics (SmPC) will replace the investigator’s brochure if the IMP is authorised in any EU Member State" http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofme... |
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Grading comment
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42 mins confidence: peer agreement (net): +1
peer agreement (net): +1product characteristics Explanation: See the references below. Your phrase would be "summary of product characteristics". תכשיר is sometimes also translated as preparation, but product works also and is more generally accepted. Reference: http://en.wikipedia.org/wiki/Summary_of_Product_Characterist... Reference: http://www.stjames.ie/GPsHealthcareProfessionals/Newsletters... |
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