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Sriramprasad ☆ India, 2020-07-18 09:06 (547 d 21:19 ago) Posting: # 21740 Views: 1,743 |
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Dear All, Greetings!!.. May i know the retention period and number of samples for Malaysian submission. I have reviewed ASEAN GUIDELINES and not found any relevant information. And also, Can we prepare Clinical study report according to ICH-E3 guidelines for Malaysian submission. Thanks in advance Regards, Sriram |
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cakhatri ★ India, 2020-08-10 08:04 (524 d 22:21 ago) @ Sriramprasad Posting: # 21848 Views: 1,163 |
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Dear Sriram, Malaysia has adopted BE guidelines from EMA. Hence you can follow EU guidelines for retention quantity https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf You can refer section 4.1 The calculation of samples required for retention quantity shall be provided by the sponsor and retained by the site Regards Chirag |
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Sriramprasad ☆ India, 2020-10-17 13:54 (456 d 16:31 ago) @ cakhatri Posting: # 22021 Views: 485 |
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Dear Chirag, Thank you for your replay. Regards, Sriram Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Ing. Helmut Schütz