Dear TC,
I thought you may want another example for your "Known Implementations" page:
ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs)
This is an implementation of the ISO/HL7 27953 Health Informatics standard for use in the pharmaceutical sector in the US, Europe, Japan, Canada and Switzerland.
The distribution of the package zip file available here (http://www.estri.org/e2br3/index.htm) contains a subfolder with a genericode distribution of code lists to be used in constructing
the messages. In implementing this approach we originally produced an information paper to introduce the concept of OIDs and codelists to our audience as this was a very different approach from the one we used previously. It is available from the FDA at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm, and was also distributed via the European Medicines Agency and the Japanese Ministry of Health. The paper is attached, see page 8 for the first introduction of genericode.
The attached .zip file contains the codes as we are distributing them, with the genericode schema, a stylesheet (based on the Crane's XSLT example), codeset file, etc.
We will have another standard to implement for 2015 and will use the same method for distributing those codelists (it will be for electronic Common Technical Dossiers).
Regards,
Raun
Regards,
Raun
Raun Kupiec
Head of Quality, EMEA HQ
Genzyme Europe
Gooimeer 10
| 1411 DD Naarden |
The Netherlands
T +31.35.699.1224 |
M +31.653.629.532 | raun.kupiec@genzyme.com
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