SEOUL -- LSK Global Pharma Services, a leading contract research organization (CRO) in South Korea, has developed a system capable of converting drug abnormalities and abnormal case reports into XML files conveniently, catering to the introduction of international guidelines on the electronic transmission of individual case safety reports.
E2B (R3) guidelines have been published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to gain greater insights into case reports and the benefit-risk profile of medicines. It is used when doctors, pharmacists, pharmaceutical companies, or patients report side effects from taking or administering medicines.
South Korea is piloting the application of E2B(R3) from June 1. Drug abnormalities and abnormal cases should be reported through screen or XML file reporting. XML is a markup language that uses tags to describe components in a file. An XML file is an extensible markup language file, and it is used to structure data for storage and transport.
Multiple individual case safety reports can be converted to a single XML file. The R3 system has a larger number of reporting items and stricter standards than its previous version. making it difficult to proceed with screen reporting if multiple cases are reported at once. Global safety databases had the hassle of generating separate XML files.
Such inconvenience can be solved with an E2B (R3) converter developed by LSK Global PS. The company said the converter's validation function allowing users to immediately check items and content in case of an error.
LSK Global PS said its converter has completed verification for immediate use. "The LSK E2B(R3) converter will standardize the reporting of individual or multiple side effects, making it easier and more efficient to strengthen safety management after drug marketing," LSK head Young-Jack Lee said in a statement on June 23.
LSK Global PS described itself as the only domestic CRO with professional personnel qualified to report safety information directly to EudraVigilance, a European system designed for collecting reports of suspected side effects.
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