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Online Registration has been closed. Onsite Registration will be available at Tokyo Big Sight.

Today we stand on the threshold of the Age of Big Data and Artificial Intelligence (AI); soon we can expect world-class medical databases to enable dramatic advances in drug safety and in research and development. The structural reforms mandated by Abenomics (the economic policies championed by the current Japanese Prime Minister Abe) are pushing government and industry to develop strategic policies in information and communications technology (ICT) that will promote innovation in areas such as medical treatment. Meanwhile, the popular media report novel treatment options for patients through genetic analysis, and new horizons for regenerative medicine technology. All of this has raised expectations for further developments in medical treatment.

Last year's topic was "Breakthrough in Regulatory Science for Patient-Engaged Medical Treatment." This year we continue our focus on advances in patient-centric drug development, with special emphasis on how AI and Big Data, particularly therapeutic and genomic information, will affect the development of next-generation medicines.  Our 2017 keynote speakers, Professor Tomohiro Sawa of Teikyo University, and 2016 Nobel laureate in Physiology or Medicine Professor Yoshinori Ohsumi of Tokyo Institute of Technology, are uniquely qualified to address these areas.

Our general sessions will cover a wide range of topics.  Sessions related to AI and Big Data will include the application of digital health options to clinical trials, and the use of disease registries and medical databases throughout the process from drug development to post-marketing safety measures. GPSP is scheduled for revision this year, and discussions are also underway regarding the practical incorporation of medical databases into post-marketing safety measures. We will address new developments in ICH and other regulatory topics, particularly in the context of reforms to enable early access to innovative drug products, and new progress on global harmonization in drug development. In addition, the Summit of Heads of Medicines Regulatory Agencies is scheduled for October of this year, so we expect to offer some "hot topic" reports.

Building on the theme of last year's conference, industry, government, and academia will discuss ways to encourage drug development including from the patient's perspective. We will also examine guidelines to optimize the use of novel medical products. Other presentations will cover development strategies for drugs for cancer and rare diseases, products for regenerative medicine, and biosimilars. Discussions will include risk management plans, labeling, risk communication, medical affairs, and health technology assessment. Additional topics will include quality management, clinical study operations, and medical devices. By emphasizing cooperation between industry, government, and academia, highlighting important developments in academic research, and offering a wide range of educational sessions, we hope to provide a broad perspective on the changes that are coming, and to offer an international  platform  for discussion of the issues and expectations that are associated with those changes.

We hope that the discussions at this year's DIA Japan conference will lead to valuable new medical developments that will truly respond to the needs and hopes of patients. We look forward to seeing you at Tokyo Big Site in November.