Streamlining Adverse Event Reporting in JAPAC

A ProPharma Medical Information (MI) Lead working alongside a pharmaceutical company successfully streamlined the adverse event (AE) reporting process in the JAPAC region, particularly addressing issues in China where a 100% rejection rate by a local safety vendor hindered timely reporting. The MI Lead facilitated collaboration between the local Chinese Affiliate and the global MI team to create a localized reporting template, provide targeted training, and introduce a quality check mechanism, ensuring alignment with stringent Chinese regulations.

These interventions dramatically improved the AE reporting process, reducing the rejection rate, cutting the reporting time by 50%, and achieving 100% on-time submissions to local authorities. This case study highlights the importance of adapting global processes to meet local needs, demonstrating the critical role of an MI Lead in enhancing efficiency and ensuring compliance in diverse regulatory environments.