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After 22-Nov-2017 EMA will disseminate Adverse Event Reports in eb2 R3 format, only. MAHs will be obliged to perform ICSR download and import for L2A/L2B (Pharmacovigilance obligations) and MLMs by themselves in e2b R3 Format. Currently implemented e2b R2 uptake solutions will become obsolete. Only a small number of reports in the MLM and L2A/L2B downloads apply for the products of the MAHs, thus, an efficient triage is required to filter out the reports which do not belong to the MAH.


RETRANS offers a comfortable and fully integrated way to parse e2b R3 files, to extract product related information for efficient triaging, and to downgrade from e2b R3 to e2b R2.


Three options for e2b R3 are available:

  • Either upgrade to Argus 8.1.2.2 which is an Accepted Database and requires minimal qualification. No efficient triage will be available. 
  • Apply patch Argus 8.9.9.99 with allows to downgrade e2b R3 files to e2b R2 files in many older Argus versions. No efficient triage will be available. 
  • Use RETRANS to downgrade e2b R3 files to e2b R2 files in a fully transparent and audited fashion. RETRANS is a cloud solution: upload an e2b R3 file and download the corresponding e2b R2 file with supplementary information in case transformations were not 1:1. Highly efficient triage capabilites will be available.


  • Use RETRANS to parse and downgrade e2b R3 files to e2b R2 files in a fully transparent and audited fashion. RETRANS is a cloud solution: upload an e2b R3 file and download the corresponding e2b R2 file with supplementary information in case transformations were not 1:1. Highly efficient triage capabilites will be available.
 
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