Pharmacovigilance (PV)
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Dear PV Forum members,
Hoping that you can help me? I am fairly new to PV and have an issue following an IB update.
The MHRA have given their approval for the update, and we can follow procedure and release this to the CI’s to use the relevant section as the RSI for SAE reviews of expectedness. However, the trial team have queried whether we can start to use it when another European country where the trial is also being conducted has yet to give its approval to the change.
I have referred to the European Commission Document – CT-3, para 5.4, and also 5.3 and 5.2.
I am hoping that Para 5.4 means that we can start to use the relevant section of the IB as the RSI, however, it refers to SmPC, not RSI?
My questions are
Are these the relevant sections to refer to in any case?
If so, do they provide me with justification to start to use the new IB across all countries?
If they are not relevant, is there another reference that I am missing that would assist?
What do other CTU’s do for multi-country trials when there is a change to the IB?
With many thanks for your help, Cathy Lisles PV&S Specialist, CTR, Cardiff.
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