What Is E2B In Pharmacovigilance?

What Is E2B In Pharmacovigilance?

In pharmacovigilance, E2B is defined as the international standard for transmitting medicine adverse event reports according to the International Conference on Harmonization (ICH). The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR).

The electronic transmission of information relating to adverse event to vital stakeholders using the International Conference on Harmonization (ICH) format is an important aspect of pharmacovigilance and global drug safety operations.

What Is an E2B Compliant File Format?

Manufacturers who wish to submit individual case safety reports (ICSRs) electronically must be capable of sending E2B or E2BM compliant SGML DTD data files as specified by International Conference on Harmonization (ICH). General guidelines for preparing these types of files can be found at ICH-M2 ESTRI Guidelines.

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 .

How Do I Prepare E2B Compliant Files?

Preparing E2B compliant files to the ICH ICSR DTD specifications requires mapping your database to the E2B data set. After the database is mapped to the E2B data set, the data then must be marked in conformance with the specified DTD.

What Does An SGML File Look Like?

SGML, or Standard Generalized Markup Language, is an international standard for the description of marked-up electronic text. SGML is a meta language, which is a means of formally describing a language. More specifically, SGML is a markup language that has been used in the publishing industry to associate document format with text.

A basic design goal of SGML was to ensure that documents encoded according to its provisions should be transportable from one hardware and software environment to another without loss of information. The structure of SGML is based on a grouping of sections and elements that are annotated by start and end tags. Tags are user-friendly phrases used to indicate the data elements contained within the tags.

What Is the Most Difficult Aspect of Preparing the File?

The most difficult and critical aspect of preparing the files for electronic transmission is mapping your database to the E2B or E2BM data set and developing the extract programs to build the conformant SGML file. The level of difficulty in performing these steps is dependent upon how close your current database resembles the E2B or E2BM data set.

What Should We Expect After We Mail the Test File?

 CDER will verify the file structure and compatibility with AERS.  If the files do not successfully load into AERS you will be notified. If the files do successfully upload into AERS, the AERS Electronic Submission Coordinator will notify you and you can begin submitting ICSRs electronically in accordance with Instructions. See (FDA Archive).

Should Files Include an EDI Header and Trailer?

Yes, all files submitted should include the EDI header and trailer. This includes test and production files submitter via the ESTRI gateway or on physical media.  The specifications for the EDI header and trailer are in the trading partner agreement and on the FDA Gateway information page.

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