CSRC, HESI, and FDA to Host CiPA Meeting

The CSRC, Health and Environmental Sciences Institute (HESI), and the FDA will host a two-day meeting titled, “New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrythmia Assay (CiPA),” on May 21-22, 2018 in Washington, D.C.

Discussion topics will include:

  • New approaches to evaluating the propensity of drugs to cause arrhythmias
  • Potential revisions to ICH E14 and ICH S7B Regulatory Guidances
  • Evolving data, ramifications, and potential regulatory implications from the Comprehensive In Vitro Proarrhyhmia Assay (CiPA)
  • The use of statistical methodologies in lieu of a positive control for QT studies
  • Updates from the FDA QT Interdisciplinary Review Team

View the draft agenda and register today!