08:30-09:00 KST
(19:30-20:00 EST) |
Registration |
Lee, Sang-Rae |
Professor / Ajou University |
09:00-09:05 KST
(20:00-20:05 EST) |
Opening Remarks |
Kim, Su Dong |
Professor / Ajou University
Chair / Foundation for Biomedical Research
|
09:05-09:15 KST
(20:05-20:15 EST) |
Congratulatory Speech |
Seo, Kyung-won |
Director General / National Institute of Food and Drug Safety Evaluation |
09:15-09:25 KST
(20:15-20:25 EST) |
Congratulatory Speech |
Bae, Byoungjun |
Chair / Korea National Enterprise for Clinical Trials |
09:25-09:30 KST
(20:25-20:30 EST) |
Welcome Address |
Oh, Young-Taek |
Dean of School of Medicine / Ajou University |
09:30-09:35 KST
(20:30-20:35 EST) |
Photograph Time |
Lee, Sang-Rae |
Professor / Ajou University |
| PART 1: Global Regulatory Trends and Outlook of Combination Products |
09:35-10:00 KST
(20:35-21:00 EST) |
【Keynote address】 The Talent Gap in the Age of Combination Products |
Pacifici, Eunjoo / Pharm.D., Ph.D. |
Professor / Associate Director / USC School of Pharmacy / DK Kim International
Center for Regulatory Science |
10:00-10:30 KST
(21:00-21:30 EST) |
Premarket Review of Combination Product and Future Insight |
Nguyen, Thinh / Ph.D. |
Director / FDA Office of Combination Product |
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 |
Amini, Tina / Pharm.D., Ph.D. |
Director / NDA Group, Medical Device Division |
11:00-11:30 KST
(22:00-22:30 EST) |
Global Perspectives on Combination Product Regulation, with focus on Europe |
Jamieson, Janine / BPharm Hons, MSc, PhD, MTOPRA |
European Editor / International
Pharmaceutical Quality (IPQ) |
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) |
Kim, Joo Hee |
Ajou University |
12:10-13:00 KST
(23:10-24:00 EST) |
Lunch (50min) |
| PART 2 : Advanced Bio combination products : Innovation and Regulatory Harmonization |
13:00-13:30 KST
(24:00~24:30 EST) |
Q&A |
Kim, Joo Hee |
Ajou University |
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 / Daegu-Gyeongbuk Medical Innovation Foundation (DGMIF) Advanced Biomaterials Team |
14:30-14:50 KST
(01:30-01:50 EST) |
Q&A (20min) |
Lee, Sang-Rae |
Professor / Ajou University |
14:50-15:00 KST
(01:50-02:00 EST) |
Break (10min) |
15:00-15:30 KST
(02:00~02:30 EST) |
Preclinical Test for Xenotransplantation Product/Device Combination Product |
Choi, Kimyung / Ph.D. |
Director / OPTIPHARM Inc.
Transgenic Animals Development Team |
15:30-16:00 KST
(02:30~03:00 EST) |
Trends of Bio Innovation : Issue & Task |
Kim, Heoung-Yeol / Ph.D. |
Director / National Biotech Policy Research Center |
16:00-16:20 KST
(03:00~03:20 EST) |
Q&A (20min) |
Lee, Sang-Rae |
Professor / Ajou University |
16:20-16:40 KST
(03:20~03:40 EST) |
Special Lecture
The Core of the Fourth Industrial Revolution :
Self Awareness
- Unique Self vs. Average Self - |
Kim, Kyung-il / Ph.D. |
Professor / Ajou University Department of Psychology |
16:40-17:00 KST
(03:40~04:00 EST) |
Closing Address / Photograph Time |
Kim, Su Dong |
Professor / Ajou University Chair /
Foundation for Biomedical Research |
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