LSK Global Pharma Services, a local contract research organization (CRO), said it has developed E2B (R3)-converter generating eXtensible Markup Language (XML) documents, which meet international standards for transmitting information of adverse events experienced by individuals.
LSK E2B (R3) converter transforms individual case safety reports (ICSR) into XML format, reducing the time required by checking articles and contents with its validation function in case of experiencing errors. E2B (R3) is an international standard adopted by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to electronically send reports of adverse responses and events caused by the drug.
Korea became an ICH member in 2016 and began running a pilot trial of E2B (R3) this month, planning to import the reporting system soon. Accordingly, when the government decides to completely replace the existing system with E2B (R3), the reports must be submitted in XML format or uploaded on the Ministry of Food and Drug Safety’s online web.
The company’s new system can also convert many ICSRs into a single XML file, improving convenience when submitting safety reports. The existing global safety database used in the nation required individual XML files for ICSR.
LSK Global PS’s drug monitoring team participated in developing E2B (R3) system, and the developers are qualified CRO experts who can directly report safety data to EudraVigiliance, a system for managing and analyzing information on suspected adverse reactions to medicines operated under the European Medicines Agency.
Drug monitoring professionals began learning EudraVigilance’s electronic reporting in 2016 and have prepared to bring in the E2B (R3).
LSK E2B (R3) has been used for dozens of reports for conversion during the pilot trial run by the drug regulator.
“LSK Global PS has been using a system that meets the requirements of E2B (R3) since 2017, and we have responded to changes beforehand by developing our own LSK E2B (R3) converter,” LSK Global PS CEO Lee Young-jack said Wednesday. “We expect LSK E2B (R3) converter will be used to strengthen the post-marketing safety management of drugs more simply and efficiently by standardizing individual and mass adverse event reports.”