Crossing the bridge - bridging studies

Wednesday 16th of April 2014
13:00-14:30
SY30, 1.5 hours

Chair: Michael Coory (Australia)

Plenary 3

13.00 – 13.30     Harmonization of Asian Bridging Study: 2013 FIP/AAPS/TFDA sponsored workshop report and future perspectives
(WE-15-01) Oliver Hu, National Defense Medical Center, Taipei, Taiwan

13.30 – 14.00     Inter-ethnic differences in drug response, bridging studies and drug development in East Asia 
(WE-15-02) Annette Gross, GSK Australia, Ermington New South Wales, Australia

14.00 – 14.30     Regulatory perspective on use of foreign clinical data for drug approval: PMDA's experience 
(WE-15-03) Yoshiaki Uyama, International Programs Pharmaceuticals and Medical Devices Agency, Tokyo, Japan