Seats are still available. You are welcome to register on-site.
Simultaneous Translation Available
Multiregional clinical trials (MRCTs) in East Asia, including Japan, China, Korea, and Taiwan, are now considered one of the promising key strategic options in new drug development. MRCTs are mentioned in the “Basic Principles on Global Clinical Trials (Reference Cases)”, which were published by the Ministry of Health, Labour and Welfare (MHLW) in September 2012. The regulatory agency stressed the importance of smooth and appropriate conduct of MRCTs in East Asia.
As understanding has deepened through experience with these trials, it is an urgent imperative for industry, government and academia to come together to discuss and resolve outstanding issues, and make improvements in collaboration internationally to activate new drug development in Asia.
This 7th DIA Asia New Drug Development Conference will provide a forum for exchange of opinions among the regulatory agencies in East Asia, including the Pharmaceuticals and Medical Devices Agency (PMDA), about how increasing MRCT data should be utilized and reviewed in New Drug Applications (NDA) in the region.
Constructive discussions will be held on how to overcome the hurdles still remaining in new drug development in East Asia using case studies of drugs that obtained approvals in Japan based upon East Asia MRCTs.
Keynote speeches will be given by highly recognized speakers from the pharmaceutical industry in China and Japan, addressing proposed strategies of development in the region. Well-recognized experts in new drug development and reviewers in regulatory agencies from Japan, China, Korea, Taiwan and other countries will attend as speakers and panelists to take part in active discussion aiming to enhance new drug development.
Following the highly appreciated session last year highlighting Market Access, one of the factors influencing development strategy, this subject will be further discussed focusing on differences in practice among countries.
In addition, an interactive workshop on new drug development in the region, which was very well received in last year’s conference, is again scheduled for the afternoon of Day 2.
Instructors who have day-to-day experience in new drug development in Asia will lead the workshop, which will be particularly helpful to those who are planning to file IND/NDA in China, Korea, and Taiwan, who are interested in regulations and clinical development operations in East Asia, or who are already working on the front line of clinical development.
Participants will have ample time for Questions and Answers and will be able to obtain valuable information, such as tips on new drug development in China, Korea, and Taiwan. Please join us at this insightful workshop.