Bioequivalence and Bioavailability Forum

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