FDAのNew Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessmentに無料で参加できます。
October 15-16, 2020 | 8:00 a.m. – 10:30 a.m. Eastern | Webcast
This webinar is FREE.
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.
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