Hi Nancy,
Having different versions of IBs for different regions can be a logistical nightmare and risks inconsistencies. I have on occasion had an "up-version" of say 2.0 to 2.1 for a region that added a specific requirement for language or content that was not in the original version as a temporary fix for that region. However, in going to version 3.0 the difference was resolved. The amount of work needed to keep different versions updated seems like a waste of resources. Regardless of all that, having a different safety profile in different regions risks an event that is a SUSAR in one region and not in another. That could be a serious regulatory concern, in my opinion.
------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------
Original Message:
Sent: 16-Aug-2021 15:27
From: Nancy Gerber
Subject: Multiple IBs for one product/same indication
We are trying to determine whether there is precedence in the industry for trials of a single compound and same indication to have more than 1 investigator brochure [IB], for example, a US IB and an ex-US IB. Often there are different versions of a protocol for different countries, but can this be done with IBs? And if regulatory agencies allow this, what are the complications related to a lack of a global single safety profile, DSUR complexities and challenges, and other scientific analyses challenges? Any experience and insights are appreciated.