In the recent years, China regulatory makes efforts to reform the review process for drug registration and issues a series of guidelines. The statistical review plays an increasing important role in the whole review process. Globally, evidence-based data-driven principles are bringing the drug development and regulatory communities together in the effort to bring innovative drugs to patients early.

The 2017 DIA China Quantitative Science Forum (QSF), with the theme of “Data Science in regulatory Decision Making”, will build a platform for quantitative scientists from regulatory, academia, global and local industry, and opens a window for other clinical trial participants, including clinical scientist, industry regulatory staff, etc, to have a deep understanding of statistical guidelines. In the forum, the experts from regulatory (CFDA, US FDA, PMDA), pharmaceutical industry, and academia, including those from China Clinical Trial Statistics (CCTS) and Clinical Data Management working group of China (CDMC), will discuss current hot topics with the participants. These will include the statistical considerations in drug consistency assessment, multi-regional clinical trials, biosimilar evaluation, real world study, etc. It will promote the communication between the quantitative scientists from global and local companies, and illustrate how quantitative science help shorten time and save costs in drug development.
Featured Sessions
  • Pharmacometrics in Drug Development
  • Clinical Trials in New Data Management Regulations
  • Bayesian Statistics in Clinical Trials
  • Early Phase Clinical Trials and Innovative Designs
  • The Design of Multi-Regional Clinical Trial: Case Examples
  • Challenges and Solutions to Innovative Biotech Companies in China - from Regulatory, Study Design and Implementation Perspective
  • Safety Data Analysis Method
  • Real World Research
  • Risk Based Monitoring (RBM) and Site Inspection Readiness
  • Artificial Intelligence and Deep Learning in Clinical Research
  • Novel Statistical Methods in Oncology Drug Development and Recent Methodology in Oncology Drug Development
  • Updates of CDISC Standard and Data Submission Requirements from USFDA, PMDA and CFDA
  • Development and Evaluation in Biosimilar Products
  • Clinical Research Design and Evaluation for Medical Devices
  • Statistical Considerations in MNC-Local Joint Drug Development and Opportunities and Challenges in China Innovative Drug Development
Who Should Attend
  • Statisticians
  • Clinicians
  • Data Management Professionals
  • Regulatory Scientists
  • Quantitative and Clinical Scientists in Academia
  • Quantitative and Clinical Scientists in Regulatory Agencies
Contact Us
Meeting Content: Runshan CHEN
Tel. +86 10 5704 2653
Email: Runshan.chen@diaglobal.org
Registration: DIA China
Tel: 010-5704 2659
Email:  china@diaglobal.org

Document Download

团体注册表 (Registration Form).xlsxdownload
2017 DIA QSF Hotel Reservation Form.pdfdownload