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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.


Three options are available:

  • Either upgrade to Argus 8.1.1 which is an Accepted Database and requires minimal qualification.
  • Apply patch Argus 8.9.9.99 with allows to downgrade e2b R3 files to e2b R2 files in many older Argus versions.
  • Use TransAlite to downgrade e2b R3 files to e2b R2 files in a fully transparent and audited fashion. TransAlite 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.


  • Use TransAlite to downgrade e2b R3 files to e2b R2 files in a fully transparent and audited fashion. TransAlite 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.
 
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