Program
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The International Society for Biopharmaceutical Statistics (ISBS), a non-profit statistics organization, will hold its VI international symposium on biopharmaceutical statistics on August 26 - 30, 2019, in Kyoto, Japan. The purpose of the symposium is to bring together statisticians, quantitative scientists, drug development professionals and regulators across the world to share and exchange information, experiences, challenges and research findings, and to promote international standards for statistical practice in the biopharmaceutical industry. The theme of the 2019 symposium is Statistical Innovation and Contribution in the Era of Precision healthcare.
The symposiums will cover a broad range of topics from discovery, early development, clinical trials, post-licensure life-cycle management of biopharmaceutical products including drugs, biologics, medical devices, and biotechnological products. The symposium will also include a regulatory mini-symposium bringing together major regulatory bodies to discuss regulatory sciences and related topics.
Specifically, the symposium covers topics in statistics, quantitative science, regulatory science in the following areas:
- pre-clinical research & discovery,
- PK/PD modeling and simulations,
- chemistry, manufacturing and control (CMC),
- design and analysis of clinical trials,
- pharmacoepidemiology and safety,
- pharmacogenomics, pharmacogenetics and system biology,
- regulatory sciences,
- biopharmaceutical globalization,
- real world data, real world evidence and decision analytics,
- statistical programming, computation, and simulation,
- information and statistical consulting.
The symposiums will include a 3-day conference to be preceded by 2 days of short courses. The short courses will cover emerging and challenging issues or topics in biopharmaceutical research, development, and regulation. There will be keynote speeches on the main theme of the symposium and invited and contributed presentations representing a variety of research areas. Parallel sessions will be arranged based on the topics submitted by the participants. Poster sessions will also be arranged and best posters will be selected for verbal presentations. Research papers presented at the symposium can be submitted for possible publications in a special issue of a statistical journal.
For more information, please refer to: https://www2.aeplan.co.jp/isbs2019/, or contact: Dr. Toshimitsu Hamasaki at: toshi.hamasaki@ncvc.go.jp.