The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that assist them with reporting safety information will be required to comply.
As with any new regulation, many questions have been raised around E2B(R3) that need to be addressed before life sciences companies can confidently implement the technology and processes they need to perform the day-to-day and periodic activities that support the regulations.
In an interview with Eugene Sefanov, marketing manager with Perficient’s life sciences practice, I provided insight into E2B(R3), the impact it is likely to have on drug safety business processes, and some ideas for how to move forward.
To read the interview, fill out the form below or click here.
