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Jasim Uddin ☆ Bangladesh, 2013-01-30 05:50 (4894 d 18:49 ago) Posting: # 9929 Views: 3,952 |
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Dear All Does anyone help me explaining what is expert report? Some regulatory authorities are still asking for Expert Report as part of registration dossier. Regards, Jasim |
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Dr_Dan ★★ Germany, 2013-01-30 10:00 (4894 d 14:39 ago) @ Jasim Uddin Posting: # 9931 Views: 3,175 |
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Dear Jasim I guess you need to provide the context of your question. In many cases (especially for EMA submissions) the expert report is a synonym for Module 2.5 "Clinical Overview" (please see Volume 2B "Notice to Applicants" Medicinal products for human use). The Clinical Overview is intended to provide a critical analysis of the clinical data in the Common Technical Document. The Clinical Overview will necessarily refer to application data provided in the comprehensive Clinical Summary, the individual clinical study reports (ICH E3), and other relevant reports; but it should primarily present the conclusions and implications of those data, and should not recapitulate them. The Clinical Overview is primarily intended for use by regulatory agencies in the review of the clinical section of a marketing application. But there are also other situations where an expert report is required (PSURs, renewals etc.). I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Jasim Uddin ☆ Bangladesh, 2013-02-03 12:40 (4890 d 11:58 ago) @ Dr_Dan Posting: # 9949 Views: 2,890 |
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Dear Dan Many thanks for your reply. We have been asked by one regulatory agency to submit Expert Report in the Administrative part of a dossier. More specificaly they mention it as "Analytical Expertise Report". Are you familiar with such requirement? Please advise me. Best regards, Jasim 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! [Helmut] |
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ElMaestro ★★★ Denmark, 2013-02-03 21:14 (4890 d 03:25 ago) @ Jasim Uddin Posting: # 9951 Views: 2,816 |
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Hello Jasim, ❝ We have been asked by one regulatory agency to submit Expert Report in the Administrative part of a dossier. More specificaly they mention it as "Analytical Expertise Report". Are you familiar with such requirement? Please advise me. It is a misnomer, I believe. The CTD has to the best of my knowledge no such document but of course there could be local regulations in your country of submission which override the CTD. Assuming this isn't the case, I think they might be asking for the bioanalytical report (+ perhaps validation) - this is just a guess. — Pass or fail! ElMaestro |
Ing. Helmut Schütz