High-profile representatives from regulatory agencies across East Asia will give their country’s perspective on clinical data evaluation for drug approval at DIA Japan’s 7th Annual Conference for Asian New Drug Development in Tokyo, April 15-16.
During a session entitled “Perspectives of Respective Regulatory Agencies in Clinical Data Evaluation for Drug Approval,” Seong-ho Kim, director of pharmaceutical safety policy division at the Pharmaceutical Safety Bureau, Korea Food and Drug Administration (KFDA), will speak regarding the Republic of Korea’s perspective, and Li-Li Su, PK/PD reviewer for the division of pharmaceutical science at the Center for Drug Evaluation, will speak for Taiwan. The Chinese perspective will be given by DIA Board President, Dr. Ling Su, PhD, and Dr. Yoshiaki Uyama, PhD, director of regulatory science research division at Pharmaceuticals and Medical Devices Agency (PMDA), will speak for Japan.
The 7th Annual Conference for Asian New Drug Development will also feature a keynote speech from Joseph Cho, managing director of R&D-based Pharmaceutical Association Committee (RDPAC) in China, addressing the “Outlook for China Pharma R&D and Market: From RDPAC Viewpoint.”
The event, 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. The main theme for discussion will be how increasing multiregional clinical trial (MRCT) data should be utilized in New Drug Applications (NDA) in the region.
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
Contact: Laura Hollis