SA-32543

Summary

The E2B spec is validated differently by the FDA vs the EMA. Pega Pharmacovigilance (PV) validates against the FDA as shipped.

Error Messages

Not Applicable

Steps to Reproduce

Not Applicable

Root Cause

Four data elements are not present in EMA:

Resolution

The population of the above four fields will have to be bypassed for EMA. Out of the box, Pega PV doesn’t distinguish the destinations based on FDA or EMA. Also, out of the above four fields, the first two are the ones which Pega PV captures today. Following is the suggested local change if you have to bypass the population of those two fields for EMA:

• For bypassing “ B.1.10.7.1g ” for EMA:
  • Override activity PegaLS-FW-AECPFW-Work-Reports!PrepareParentDataForE2B to the implementation layer
  • 
  • Do not populate the “Comments” in step 4.1 if the report is being
    generated for an EMA locale
• For bypassing “ B.2.i.0 ” for EMA:
  • Override activity PegaLS-FW-AECPFW-Work-Reports!PrepareEventDataForE2B
  • Bypass population of primarysourcereaction in step 2 for EMA
  •