Hello,
I was on a meeting last Friday with MHRA GCP inspector as one of the presenters. He mentioned that RSI not being up to date is one of the most frequent audit findings. He recommended that RSI should be up to date with the latest safety information from ongoing clinical trials and companies have to make sure they use the most up to date RSI in all their IBs submitted to different countries. If the RSI is not up to date then this will be seen as underreporting safety information.
I suggest you make sure your RSI is up to date. I don't think using SmPC is good option but I will leave to my USA colleagues to comment on this.
Have a great week,
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist (Clinical trials)
Solutions OP Ltd
https://solutionsop.co.uk/United Kingdom
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Original Message:
Sent: 22-Apr-2024 22:56
From: Anonymous Member
Subject: Investigator Brochure: EU SmPC attached as RSI
This message was posted by a user wishing to remain anonymous
Hello All,
I'm updating the IB for a product which is approved in Europe, the US and other countries. My EU PV colleagues say the RSI table should be pulled from the IB and instead the EU SmPC be attached to the IB with a reference from the RSI section to the attached SmPC. They are citing a CTFG or CTCG guidance document from 2017. I can understand wanting to align the IB with commercial labeling (regarding AEs) but I can't see this being a viable option and cannot imagine submitting an IB to FDA with an EU SmPC attached. In addition, the indication in the ongoing clinical trial does not exactly match the EU SmPC indication. Does anyone have any ideas about this? Many thanks in advance!