08:30-09:00 KST
(19:30-20:00 EST) |
Registration |
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09:00-09:05 KST
(20:00-20:10 EST) |
Opening Remarks |
김수동
Kim Su Dong |
아주대학교 교수
Professor / Ajou University |
09:05-09:15 KST
(20:10-20:20 EST) |
Congratulatory Speech |
서경원
Seo Kyung-won |
식품의약품안전평가원 원장
Director General / National Institute of Food and Drug Safety Evaluation |
09:15-09:25 KST
(20:15-20:25 EST) |
Congratulatory Speech |
배병준
Bae byoung-jun |
임상시험재단 이사장
Chairman of the director / korea national enterprise for clinic trials |
09:25-09:35 KST
(20:25-20:35 EST) |
【Welcome Address |
오영택
OH Young Taek |
아주대학교 의과대학 학장
Dean of School of Medicine / Ajou University |
| PART 1: Global Regulatory Trends and Outlook of Combination Product |
09:35-10:00 KST
(20:35-21:00 EST) |
【Keynote address】 The talent gap in the age of combination products |
Pacifi Eunjoo, Pharm.D., Ph.D. |
Chair and Associate Professor, Department of Regulatory and Quality Sciences
President, Pharmacy Faculty Council (PFC)
Associate Director, DK Kim International Center for Regulatory Science
USC School of Pharmacy |
10:00-10:30 KST
(21:00-21:30 EST) |
Premarket Review of Combination Product and Future Insight |
Nguyen, Thinh |
(FDA/OC) |
10:30-11:00 KST
(21:30-22:00 EST) |
Drug Device Combination Products in the EU & the impact of the new EU Medical Device Regulation |
Tina Amini, Pharm.D., Ph.D. |
NDA Group, Medical Device Division Director |
11:00-11:30 KST
(22:00-22:30 EST) |
Global Perspectives on Combination Product Regulation, with focus on Europe |
Janine Jamieson, BPharm Hons, MSc, PhD, MTOPRA |
International Pharmaceutical Quality (IPQ) , Europena Editor
Board Member for TOPRA (The Organisation for Professionals in Regulatory Affairs |
11:30-11:35 KST
(22:30-22:35 EST) |
Break (5min) |
11:35-12:10 KST
(22:35-23:10 EST) |
Q&A (35min) |
12:10-13:00 KST
(23:10-24:00 EST) |
Lunch (50min) |
| PART 2 : Advanced Bio combination product : Innovation and Regulatory Harmonization |
13:00-13:30 KST
(24:00~24:30 EST) |
해외연자 사전 Q&A |
사회자 |
|
13:30-14:00 KST
(24:30~25:00 EST) |
Advanced Products: Tissue Engineering, Cell Therapy, and Gene Therapy's Preclinical Trials |
Moon Kyoung-Sik, Ph.D |
Group Head, Biologics Safety Research Group / Korea Institute of Toxicology |
14:00-14:30 KST
(01:00~01:30 EST) |
Turning Medical Wastes to Medical Products: Seeking Innovation into the R&D |
Jung Bongsu, Ph.D |
Principal Research Scientist, Team Leader of Advanced Biomaterials Team / Daegu-Gyeongbuk Medical Innovation Foundation(DGMIF) |
14:30-15:00 KST
(01:30~02:00 EST) |
Q&A (30min) |
15:00-15:30 KST
(02:00~02:30 EST) |
Preclinical Test for Xenotransplantation Product/Device Combination Product |
Choi Kimyung, Ph.D |
Director of transgenic animals development team / OPTIPHARM Inc. |
15:30-16:00 KST
(02:30~03:00 EST) |
Trends of Bio Innovation : Issue & Task |
Kim Heoung-Yeol, Ph.D |
Director of Center / National Biotech Policy Research Center |
16:00-16:20 KST
(03:00~03:30 EST) |
Q&A (30min) |
16:20-16:30 KST
(03:00~03:30 EST) |
Break (10min) |
16:30-16:50 KST
(03:30~03:50 EST) |
융합인재, 4차 산업혁명 (미정) |
김경일
Kim kyun-il |
아주대학교 교수
Professor / Ajou University |
16:50-17:00 KST
(03:50~04:00 EST) |
Closing Address / Photograph Time |
㈜경연전람