Using Oracle Argus Safety to Comply with Japan’s Safety and Pharmacovigilance Regulations

by Eugene Sefanov

Life sciences companies, or their affiliates, with a presence in Japan, must comply with the country’s stringent safety and pharmacovigilance regulations. To meet the reporting and submission requirements, typically set by the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), organizations often choose to deploy sophisticated adverse event reporting systems to help streamline their drug safety and pharmacovigilance operations.

Oracle’s Argus Safety, coupled with the Argus Safety Japan (Argus J) module, is one of the few truly global systems that can meet the critical needs of sponsors and CROs doing business globally, and specifically in Japan.

Please join BioPharm’s KC Katsuyama, director of safety and pharmacovigilance, APAC, for a free one-hour webinar in which he will discuss the features and benefits of Argus J.

Register to view the webinar at https://cc.readytalk.com/r/lc2nzo075hn8&eom

For more information about BioPharm Systems, please visit www.biopharm.com.