TOKYO, JAPAN— March 4, 2013 — Professionals in new drug development and regulatory agencies will discuss the challenges and benefits of using multiregional clinical trial (MRCT) data at the DIA’s 7th Annual Conference for Asian New Drug Development in Japan, April 15-16.
The conference, to be held at Nakano Sunplaza in Tokyo, 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.
Program Chair Dr. Kihito Takahashi, MD, PhD, vice president Japan development and medical affairs division, GlaxoSmithKline K.K., 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 (MHLW) 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.
“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.” The 7th Annual Conference for Asian New Drug Development 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. For more information about the event, or to register, visit www.diahome.org/AsiaNewDrugDev
ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India and Beijing, China. www.diahome.org