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