21-22 August |     Main Conference

In recent years, biotechnology and pharmaceutical innovation have achieved remarkable development in China. The rapid development of innovative drugs has promoted the innovation of experimental design and the demand for data management and analysis talents. Meanwhile, the application of big data and artificial intelligence (AI) in the fields of health and pharmacy has also become a hot spot in the industry. How to realize data-driven innovation has become the focus of technological innovation in pharmaceutical enterprises. With the theme of "Breaking Boundaries:New Era of Clinical Development", 2019 QSF provides a platform for quantitative scientists from regulators, academia, domestic and multi-national pharmaceutical companies to discuss data science innovation. It also provides insights into the progress of data science methods and their application in drug development for other key players in drug development, including clinical, registration and operational personnel. In QSF, to the regulatory agencies, pharmas, the experts from China Clinical Trial Statistics (CCTS) Working Group and Chinese Clinical Data Management Committee (CDMC) will work with participants to discuss the current hot topics, including I/O drug research and development of innovative design, the study of early clinical dose grade design, using real world data and AI to accelerate the process of new drug R&D, etc.

Main Contents

• Breaking Boundaries in New Era of Clinical Development

• Safety and Benefit-Risk Assessment: Planning and Execution

• Novel Design in Oncology Studies

• Innovative Thinking in Real World Evidence Study

• Opportunity and Challenges in Immune-Oncology Development

• The Recent Development and Perspectives on ICH E9(R1) Estimand

• Considerations in the Trial Design for Combination Therapy | NEW

• The Implementation of Multiple Testing Control, Including Refresher of The Basics | NEW

• Modeling/Model-based Development | NEW

• Enrichment Design | NEW

• Application of Innovative Methods in Vaccine Clinical Development | NEW

• Challenges and the Changing Landscape of Data Monitoring Committees (CMDC) | NEW

• Automation in Clinical Trials | NEW

Hosting and Exhibition Contact:

Fei XIE | email. fei.xie@diaglobal.org | Tel. +86.10. 5704 2652 

Meeting Agenda

19957_QSF_program.pdf