Follow up national scientific advice
Serbian translation: Kontrolni/naknadni nacionalni stručni savet
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| 21:10 Oct 2, 2014 |
| English to Serbian translations [PRO] Medical - Medical: Pharmaceuticals / Clinical study | |||||||
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|  Selected response from: Sladjana Daniels Serbia Local time: 07:29 | ||||||
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| 4 | Kontrolni/naknadni nacionalni stručni savet |
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Answers
17 mins confidence: 
| follow up national scientific advice Kontrolni/naknadni nacionalni stručni savet Explanation: Moj predlog: nacionalni stručni savet. Ovde ima lepo objašnjeno šta je stručni savet i na koja tri nivoa može da se zatraži: http://www.wainwrightassociates.co.uk/Product-Types/Medicine... A follow-up već uklopite prema svom kontekstu... -------------------------------------------------- Note added at 18 mins (2014-10-02 21:29:13 GMT) -------------------------------------------------- Scientific Advice in the EU Scientific advice can be obtained at any stage of drug development and prior to the submission of a marketing authorisation application or post-authorisation procedure (e.g. significant variation applications). It is available to help companies answer important questions related to the particular components of a drug development programme whether of a quality (CMC), non clinical or clinical nature. ... There are three routes to gaining scientific advice in the EU: • National • Centralised • Parallel National Scientific Advice: Companies can seek advice from one or multiple national agencies and can make a decision on where to go based on anticipated geographical distribution of the products and timing. The UK offers joint advice with the National Institute for Health and Clinical Excellence (NICE). |
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