Stream: research
Topic: ICH E2B(R3)
Gustav Vella (Jul 21 2020 at 14:50):
Hi there, I had a vague impression of seeing an implemention of - or an intention by EMA to implement - FHIR profiles for the individual case safety reports (ICSRs). Can't find anything of the sort.
Does anyone here have any information whether this is done, is being done or will be done? We are re-implementing our Pharma E2B interface and I was hoping to make use of the efforts in FHIRing up our Safety System.
Gustav Vella (Jul 22 2020 at 06:44):
@Jean Duteau @Rik Smithies - I've found this recent post https://chat.fhir.org/#narrow/stream/179240-Announcements/topic/.5BHL7.20JIRA.5D.20FHIR.20Implementation.20Guide.20for.20ICSR.20Submissions.2E.2E.2E - however no specific mention of ICH E2B(R3). Is this within the scope of the IG ?
Jean Duteau (Jul 22 2020 at 14:14):
Yes, sort of. The guide is focusing on FDA submissions to FAERS and VAERS. FAERS currently uses ICH E2B(R2) with local extensions while VAERS uses ICH E2B(R3) with local extensions. I have mapped both R2 and R3 to FHIR but our profiles only handle the Transfusion and Vaccination use cases.
Gustav Vella (Jul 22 2020 at 18:33):
@Jean Duteau that's very helpful, very precise. Is the work a closed job or can we build on top of it and extend beyond your use cases?
Jean Duteau (Jul 22 2020 at 18:35):
You should reach out to the HL7 Vulcan Accelerator. I presented to them last week and they will be doing exactly what you asked - building on top of it and extending beyond our use cases. Basically, I believe that they'll take my mapping and then build more in-depth profiles off of that.
Gustav Vella (Jul 22 2020 at 18:36):
Thanks!
Last updated: Apr 12 2022 at 19:14 UTC
