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[Session 5] Lessons Learned from Actual Experience - Case Example of Drug Approval in Asia through Global Development -
Session Chair(s)
Ryuji Nagata, PhD
Consultant, Regenerative Medicine Promotion Office
EPS Corporation, Japan
New drug development is a long, complicated and expensive process. Many factors contribute to the increasing challenges of developing medicines, including changing science, increasing regulatory requirements, and clinical trial recruitment and retention. Pharmaceutical companies elaborate a new compound clinical development plan to efficiently confirm safety, efficacy and patient benefit as well as to accelerate the process of bringing the new drug to market as early as possible. One of their options is to utilize MRCT in Asia. In this session, experienced speakers will describe “specific successful cases of drug development in Asia,” which will be of great benefit as you work to deliver your innovative drugs to patients in Asia.
Speaker(s)
Asia NDA Strategy Utilizing Global Clinical Study
Atsushi Nonogaki, MSc
Daiichi Sankyo Co., Ltd., Japan
Manager, Regulatory Affairs Group, Asia Development Department, R&D Division
From MRCT to NDA: Experience from Korea
Hyun-Ju Yang
Daiichi Sankyo Korea Co., Ltd., Korea, Republic of
Senior Director/Pharmacist/MBA, Medical Division (CD/RA/Pricing/PV)