Online registration has been closed, but we still accept your registration by email at japan@diaglobal.org or register at the venue. Please call at +03-6214-0574 for the details.

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We are proud to announce that 10th DIA Asia New Drug Conference in Japan on April 13-14, 2016. We updated the name of this conference from “DIA Annual Conference in Japan for Asian New Drug Development” to better reflect the broad range of issues to be discussed for better drug development and fostering of innovation in Asia.

With clinical development in Asia growing so rapidly, there is a need for local regulatory authorities to quickly bring their processes and guidelines up to date and to be in alignment with the changing clinical trial environment in each country. These efforts, however, have posed a significant challenge to regulatory authorities in charge of the review and approval of new products. In addition to an increasing workload associated with precise review, regulatory authorities must now contend with faster review and approval. The pharmaceutical industry is also changing its business model in response to recent regulatory changes.

Much the same is true on labeling and pharmacovigilance, including the Risk Management Plan, recently required in East Asia countries. An increase in drug safety concerns in recent years has led to raising the regulatory hurdles. Proactive pharmacovigilance throughout the product life cycle is the way forward in Asia region. It has been a constant challenge to standardize pharmacovigilance in Asia because of varied geographical, cultural and medical practices in this region. Given these challenges, the need for cooperation and convergence has been recognized. It is crucial for sustainable and successful drug development that all stakeholders collaborate closely and early in the development process of medical treatments.

At last year’s conference, regulators from four East Asian countries, including China, and regulatory affairs professionals from pharmaceutical companies in various countries had active discussions on current challenges and opportunities. This year, regulators from Asian countries and speakers with varied expertise will share their valuable experiences and insight to discuss what we can do better in the era of globalized drug development and life cycle management. A variety of hot topics that catalyze the creation of fresh ideas will be featured at the conference, including:
• The latest regulatory information
• A real-world case study of Asia MRCT
• Efficient drug development using Asia MRCT
• Efficient safety information management

The 10th DIA Asia New Drug Conference in Japan promises to be one of the most exciting opportunities for those who are seeking to broaden their professional network. We wish you all an enjoyable and informative conference.