International harmonization of bioanalysis regulation: Discussion in Global Bioanalysis Consortium harmonization teams

摘要

The Japan Bioanalysis Forum was established in August 2011 by delegates from industry, regulators and academia. The forum was founded as the place for discussion on regulated bioanalysis in Japan, where the bioanalytical topics in the west such as the American Association of Pharmaceutical Scientists/US FDA workshops have long been of interest. The forum's 3rd symposium presented the latest updates on activities in the Global Bioanalysis Consortium to approximately 300 attendees of industry, regulators and academia. This article provides an overview of its highlights.