About AFPT - Club Phase 1 webinar: Updates of the QT/QTc evaluation guidance: industry and expert perspectives
AFPT - Club Phase 1 webinar: Updates of the QT/QTc evaluation guidance: industry and expert perspectives
The regulatory landscape for assessing the proarrhythmic risk during drug development is changing. The recent update considers an integrated approach of the ICH14 and S7B guidances. Under certain conditions, this brings new insights for the industry, offering the use of non-clinical data during clinical development to overcome the limitations when a high clinical exposure scenario cannot be assessed.
The speakers will provide their perspective of this regulatory update and its impact during drug development.
- Dr. Philippe Grosjean (PhD) - ECG Subject Matter Expert – Sanofi R&D, France
- Dr. Pierre Maison-Blanche (MD) – Cardiac Safety Expert – Public Hospitals of Paris (AP-HP), France