THE ROLE OF PHARMACOMETRICS IN REGULATORY SCIENCE: pre-meeting workshop for the World Conference on Pharmacometrics (WCoP)

THE ROLE OF PHARMACOMETRICS IN REGULATORY SCIENCE: pre-meeting workshop for the
World Conference on Pharmacometrics (WCoP)

Sunday, August 21, 2016 08:00 – 15:15
Brisbane Convention and Exhibition Centre Brisbane, Australia
Meeting Room P3

AGENDA: WCoP pre-meeting workshop draft agenda_FINAL.pdf (173.4 KB)

Registration Link

Background

The FDA’s Critical Path Initiative identified modeling and simulation as a priority area of active research opportunities in regulatory science. Regulatory science is now recognized as more than just developing new methods for evaluating therapeutic candidates in a more efficient manner. It requires a cultural shift relating to how drug developers, patients and regulators view the tradeoff between risk and reward. Collaboration among disciplines offers a particularly productive venue for developing a regulatory science workforce. The Coalition Against Major Diseases (CAMD) is convening a pre-meeting workshop in association with WCoP with the goals of discussing with the modeling and simulation community, the areas of cross-fertilization between pharmacometrics and regulatory science. The value proposition of quantitative drug-disease-trial models as drug development platforms will be highlighted, and case studies of the potential of novel and integrated data sources for the development of such models will be shared.

Meeting Topics

  • Strategic ISoP/C-Path Alliance for the Advancement of Pharmacometrics and Regulatory Science
  • Regulatory Science and Quantitative Drug Development Tools
  • Digital Biomarkers and Quantitative Model
  • Case Studies of Pharmacometrics Applied in Regulatory Science

Registration Link