Contributing to human resource development on biologics in Asia-Pacific

Introduction of our activitiesWhat is the APEC CoE?

Part of the workshop materials held on the web in 2022

The Asia-Pacific Economic Cooperation (APEC) and Regulatory Harmonization Steering Committee (RHSC) have established linkages with other harmonization/convergence initiatives, training institutions, and key players in order to avoid duplication of effort, promote complementary action, and make maximum use of resources. As a part of regulatory harmonization activities, the RHSC has initiated the establishment of the Center of Excellence (CoE). The CoE training benefits all parties that are engaged in the healthcare field by continuously providing quality training.

On June 15, 2020, Kobe University was certified as a CoE in the field of biotherapeutics by the APEC-LSIF (Life Sciences Innovation Forum)-RHSC. It was the second CoE to be certified by the APEC-LSIF-RHSC in Japan after the Pharmaceuticals and Medical Devices Agency (PMDA), and the first among academic institutions.

Kobe University has invited regulatory officials from Asia and other parts of the APEC region to Kobe to participate in regular English-language training programs on biologics manufacturing process development and GMP inspections, including classroom lectures and practical training.