14:35 - Jian Wang (Health Key Issues that Regulators should Consider While 14:55 Canada) Reviewing CT Data 14:55 - Panelists: Invited Discussion 15:15 Participants 15:15 - Mike Ward (Health ICH Current Status and APEC Regional Harmonization 15:45 Canada) Efforts 15:45 - Coffee Break 16:00 Panel Discussion - Opportunities for regulatory convergence Yvonne Khoo (NPCB, Ministry of Evaluation of Biologics in Malaysia Health, Malaysia) Yasuhiro Kishioka Evaluation of Biologics in Japan (PMDA) Panellists: 1) China (HongZhang Yin, CFDA) 2) Chinese Taipei 16:00 - (Fia (Ya-Ting) Chen, 17:20 Ministry of Health and Welfare) Discussion: 3) Japan (Yasuhiro Kishioka, 1. How do Various Economies use WHO and ICH PMDA) Guidelines? 4) Korea 2. What are the opportunities for regulatory (Jeewon Joung, MFDS) convergence? 5) Malaysia (Yvonne Khoo, NPCB, Ministry of Health) 6) Thailand ( Prapassorn Thanaphollert, Ministry of Public Health) 17:20 - Review of the day and wrap up • Ivana Knezevic (WHO) 17:50 Conclusion and read-out from Day 1 • 18:00 - Reception (Hosted by AHC & MFDS) Day 2: Thursday, September 26
14:35 - 14:55 Jian Wang (Health Canada) Key Issues that Regulators should Consider While Reviewing CT Data 14:55 - 15:15 Panelists: Invited Participants Discussion 15:15 - 15:45 Mike Ward (Health Canada) ICH Current Status and APEC Regional Harmonization Efforts 15:45 - 16:00 Coffee Break 16:00 - 17:20 Panel Discussion - Opportunities for regulatory convergence Yvonne Khoo (NPCB, Ministry of Health, Malaysia) Evaluation of Biologics in Malaysia Yasuhiro Kishioka (PMDA) Evaluation of Biologics in Japan Panellists: 1) China (HongZhang Yin, CFDA) 2) Chinese Taipei (Fia (Ya-Ting) Chen, Ministry of Health and Welfare) 3) Japan (Yasuhiro Kishioka, PMDA) 4) Korea (Jeewon Joung, MFDS) 5) Malaysia (Yvonne Khoo, NPCB, Ministry of Health) 6) Thailand ( Prapassorn Thanaphollert, Ministry of Public Health) Discussion: 1. How do Various Economies use WHO and ICH Guidelines? 2. What are the opportunities for regulatory convergence? 17:20 - 17:50 Ivana Knezevic (WHO) • Review of the day and wrap up • Conclusion and read-out from Day 1 18:00 - Reception (Hosted by AHC & MFDS) Day 2: Thursday, September 26
RHSC_Biotherapeutic%20Product%20Roadmap_Apr25_2014.docx