15
octubre, 2020 jueves
CDER SBIA Webinar: New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment
Webinar
,
This webinar will provide an overview of the high-level principles and rationale behind the new interconnected Questions & Answers (Q&As) to ICH E14 and S7B. We will present and discuss examples and respond to questions which can be submitted via the Q&A pod during the webinar. The new Q&As describe how nonclinical assays can be […]
This webinar will provide an overview of the high-level principles and rationale behind the new interconnected Questions & Answers (Q&As) to ICH E14 and S7B. We will present and discuss examples and respond to questions which can be submitted via the Q&A pod during the webinar.
The new Q&As describe how nonclinical assays can be used as a part of an integrated risk assessment prior to first-in-human studies as they are used today, but also in later stages of development as a part of a combined nonclinical-clinical integrated risk assessment when decisions are being made about the potential for proarrhythmic risk at the time of a marketing application.
Submitted questions will be discussed at the end of each of the two sessions by panels of the Implementation Working Group (IWG) members.
More information: www.fda.gov