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.
Hi Ramya,
Hope all is well.
I am interested to find out if there are any reporting obligations for supplements (vitamins, other supplements). Any guidance is appreciated.
Best
Ameet
Hi Ameet,
Yes we have guidelines for supplements. I will be updating soon about it.
Many thanks, Ramya
your contact pls
Please contact via email allaboutpv.training@gmail.com
great work.
Hi Ramya,
I am a new fellow in PV and would like to dive deep into understanding the documents/guidelines/reports that are most common in the department. What books would you suggest?
Thanks!
Hi Sabrina,
You can read ICH guidelines, GVP guidelines and Cioms modules. They contain all the necessary information required for PV.
Hello Ramya,
I am interested in post market surveillance and the global regulation reference & guidance’s around it. Could you help?
Hi Ramya,
What are the reporting requirements for INvestigator Sponosored trials and Non-Companay sponsored trials? Our company owns same IMP but what are the reporting obligations for these studies.
Thanks.
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