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ICH E2B(R3): Are You Ready For The New Update?

Pharmacovigilance Team


The International Conference on Harmonisation (ICH) has defined E2B as the international standard for transmitting medicine adverse event reports. The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR). Eventually, the need for the exchange of high volume of safety information world-wide efficiently and automatically has led to periodic revisions of the E2B document. Since 2001, when E2B(R2) was implemented, there have been many developments in regulatory reporting requirements and pharmacovigilance practices. Recently, the ICH E2B(R3) and M2 Expert Working Groups (EWGs) jointly developed an implementation guide on the standards adopted for electronic transmission of ICSRs. It includes new requirements that will require compliance by product manufacturers (and the organizations that assist them with reporting safety information).

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Topics: ICH E2B(R3), Pharmacovigilance, Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), Adverse Events (AEs), Patient Safety, Good Pharmacovigilance Practices, Safety Database, Standard Operating Procedures (SOP)

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, Randomization, Serious Adverse Events (SAEs), Quality Control, CDISC, SAS Programming, Remote Monitoring, On-Site Monitoring, FDA, Visualization, Standardization, Remote Data Capture, Source Data Verification (SDV), Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

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