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Monday, August 30, 2010

What is the difference between E2B and E2BM?

E2B is the international standard for the transmittal of electronic safety data signed as an ICH Step 4 document in July1997. E2BM clarifies and resolves issues raised in the three regional pilot studies. The revised document (E2BM) is intended to further advance the electronic exchange of safety information and approach a true EDI (Electronic Data Interchange) standard. The E2B document is implemented by M2 Specification Version 2.24 DTD Version 2.0. The E2BM document is implemented by M2 Specification Version 2.3 DTD Version 2.1

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