Individual case safety reports

E2B(R3) Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports... 

This working party considers safety-related issues at the request of the CPMP and national authorities, resulting in the harmonization of the summary of produet eharae-teristics and package leaflets of marketed products. Regular videoeonferenees are held with the U.S. Food and Drug Administration (FDA) to discuss issues of mutual interest. A pilot project has been started for the electronic transmission of individual case safety reports with a restricted number of participants from national authorities and marketing authorization holders. 

ICH E2B(M) Clinical Safety Data Management data elements for transmission of individual case safety reports. 

CPMP Joint Pharmacovigilance Plan for the Implementation of the ICH E2B Ml and M2 Requirements Related to the Electronic Transmission of Individual Case Safety Reports in the Community. 

Specification (M2)], ICH/287/95 [Guidance on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports (E2B)], ICH/288/95 [Guidance on Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs (E2C)], and ICH/377/95 [Clinical Safety Data Management Definitions and Standards for Expedited Reporting (E2A)]. 

Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the Pre-and Post-Authorisation Phase in the EEA (EMEA/115735/2004) (Eudra Vigilance TIG adopted September 2004)... 

Postmarketing Expedited and Periodic Individual Case Safety Reports. This allows for voluntary electronic submission of all postmarketing individual case safety reports, whether expedited or periodic, in electronic format in place of paper. 

AERS. A pilot program for electronic submission of individual case safety reports is now being conducted with pharmaceutical manufacturers with approved products. The format follows the International Conference on Harmonization (ICH) standards. For more information on the ICH, please contact Timothy Mahoney at mahoneyt cder.fda.gov. 

For more information on the proposed electronic submission of individual case safety reports, see 63 FR 59746, Advanced Notice of Proposed Rule-making for Electronic Reporting of Postmarketing Adverse Drug Reactions, published on November 5,1998. 

International Conference on Harmonization Guideline on Data Elements for Transmission of Individual Case Safety Reports. This document s efforts focus on quality control/quality assurance endeavors to ensure accuracy and to promote validation in the handling of case safety reports for both preapproval and postapproval periods. It covers both adverse drug reaction and adverse event reports. 

Figure 34.4 Flowcharts for reportability assessment (a) assessment of expedited reportability (Europe) investigational medicinal products (IMPs) (b) assessment of reportability of individual case safety reports (ICSRs) in Europe post-marketing...

Transmission of Individual Case Safety Reports in the Community. 

Over the past few years, the relative emphasis of pharmacovigilance activities has shifted (Figure 6.1). In the past, most pharmacovigilance departments at biopharmaceutical companies focused on the handling of individual adverse event reports (called individual case safety reports [ICSRs]) with less attention paid to systematic analysis and review of aggregate adverse... 

Tengstrand M, Star K, van Puijenbroek EP, Hill R. Alopecia in association with lamotrigine use an analysis of individual case safety reports in a global database. Drug Saf 2010 33(8) 653-8. 

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