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Hebrew to English translations [PRO]
Medical - Medical (general) / Clinical Trials | | Hebrew term or phrase: איפיוני התכשיר | בבקשה למחקר קליני:
"תמצית איפיוני התכשיר" |
| | | (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....
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Note added at 41 mins (2012-01-17 20:05:14 GMT)
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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... |
| Selected response from:
 Ty Kendall
United Kingdom
Local time: 10:53
| Grading comment TODA
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42 mins confidence:  peer agreement (net): +1
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