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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)
Atsushi Nonogaki, MSC
Manager, Regulatory Affairs Group, Asia Development Department, R&D Division, Daiichi Sankyo Co., Ltd., Japan
Asia NDA Strategy Utilizing Global Clinical Study
Hyun-Ju Yang
Senior Director/Pharmacist/MBA, Medical Division (CD/RA/Pricing/PV), Daiichi Sankyo Korea Co., Ltd., Korea, Republic of
From MRCT to NDA: Experience from Korea
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