The electronic transmission of adverse event information to stakeholders, using International Conference on Harmonization (ICH) E2B standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3) is the current version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard.
What is E2B?
E2B doesn’t have a direct translation. The ICH guidelines have designated “E” to stand for efficacy and the guidelines relates to design, conduct, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes, and the use of pharmacogenetics and genomics techniques to produce better targeted medicines. All “E2” guidelines
relate to pharmacovigilance. The official E2B(R3) document is titled “Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports.”
There was a time when people shared safety information on a hand-written forms. Then, E2B was introduced. E2B essentially defines what data elements need to be transmitted in individual case safety reports (ICSRs), regardless of the source or destination. E2B(R3) is the fourth major revision of E2B guidelines. E2B (R3) is based on the International standard HL 7, which allows a variety of clinical systems to exchange data.
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