Information

Program

Time	Session	Speaker
09:00–09:30	Registration	Sang Rae Lee (moderator) Professor / Ajou University School of Medicine
09:30–09:35	Opening Remarks	Sang Rae Lee (moderator) Professor / Ajou University School of Medicine
09:35–09:40	Congratulatory Speech	Su Jeong Son Director / National Institute of Food and Drug Safety Evaluation Pharmaceutical and Medical Device Research Department
09:40–09:45	Congratulatory Speech	Seon Yong Kim Executive director / Daewoo Educational Foundation
09:45–09:50	Congratulatory Speech	Sang In Kim Executive Vice President / Ajou University-Industry Cooperation
09:50–09:55	Welcome Address	Su Dong Kim Director / RSCP Center
09:55–10:00	Photograph Time
PART 1: Strategy and Policies for Better Regulation of Combination Products
10:00-10:25	Keynote Address Managing Science and Regulatory Science for Combination Products	Daryl L. Davies Associate Dean of Undergraduate Affairs, USC School of Pharmacy
10:25–10:50	Global Combination Products Landscape and Harmonization Opportunities	Susan Neadle Principal Consultant & President Combination Products Consulting Services LLC
10:50-10:55	Break Time
10:55-11:20	How can Collaborative Research Support and Shape Regulatory Policies and System Strengthening?	Magda Bujar Senior Manager, Centre for Innovation in Regulatory Science, Ltd
11:20-11:45	A Study of Application of Expedited Licensing System to Combination Products and Necessity of Improvement of Current Legal System	Seung Han Oh Professor / Ajou University Law School
11:45-12:15	Q&A	Ju Hee Kim Professor / Ajou University School of Medicine
12:15-13:30	Lunch
PART 2: Technological Development Trends and Commercialization Strategies for Combination Products
13:30-13:55	Overseas regulatory trends and case-sharing research on combination products	Young Kim CEO / Synex
13:55–14:20	International Regulatory Trends in the New Drug Delivery System	Ma Se Lee Vice President / Inventage Lab
14:20–14:45	Technology Trends and Regulations of Microneedle Patch	Seung Yun Yang Professor / Pusan National University Department of Biomaterials
14:45–14:50	Break Time
14:50–15:15	Examples and Prospects of Commercialization of Combination Products through Convergence of Manufacturing Technologies	Su Jin Park CEO / OTIKOREA
15:15-15:40	Technology Transaction Strategies and Opportunities for the Development of Combintion Products	Kang oh Lee CEO / Snvia
15:40–16:30	Panel Discussion (Harmonization of Technology Commercialization and Regulatory Policy)	Ju Hee Kim Professor / Ajou University School of Medicine
16:30-16:40	Break Time
16:40–16:55	Special lecture (Artificial Intelligence and Smart Farms)	Man Su Cho Professor / Kookmin University Graduate School of Techno Design
16:55–17:00	Closing Address & Photograph Time	Su Dong Kim Professor / Ajou University

* The program is subject to change due to the host's circumstances.

Inquiry

Regulatory Strategy Center for Combination Product

Tel. +82-31-219-3473 Email. acrs@ajou.ac.kr