Drug Information Association (DIA) will be organising two day 7th Annual Conference for Asian New Drug Development on April 15 and 16 at Nakano Sunplaza in Tokyo, Japan.
At the conference, professionals in new drug development and regulatory agencies will discuss the challenges and benefits of using multi-regional clinical trial (MRCT) data.
This conference will provide a forum for exchange of opinions among pharmaceutical industry professionals, academia, and the regulatory agencies in East Asia, including the Pharmaceuticals and Medical Devices Agency (PMDA), about how increasing MRCT data should be utilized in New Drug Applications (NDA) in the region.
Dr Kihito Takahashi, MD, PhD, vice president Japan development and medical affairs division, GlaxoSmithKline KK, and programme chair said, “MRCTs in East Asia, including Japan, China, Korea, and Taiwan, are now considered one of the promising key strategic options in new drug development. The Ministry of Health, Labour and Welfare (MoHLW) stressed the importance of smooth and appropriate conduct of MRCTs in East Asia in “Basic Principles on Global Clinical Trials (Reference Cases)”, published in September 2012.”
Dr Takahashi further added, “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 Annual Conference will feature keynote presentations by high-profile 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.
This programme will benefit clinical development professionals, personnel involved in regulatory affairs, personnel at clinical study sites and personnel at CROs and SMOs.