October 15-16, 2020 | 8:00 a.m. – 10:30 a.m. Eastern | Webcast

This webinar is FREE.

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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.

INTENDED AUDIENCE

• Nonclinical and clinical scientists involved in the performance, assessment or evaluation of studies under ICH E14 and S7B from regulators, pharmaceutical industry, contract research organizations and instrument providers, as well as pharmaceutical/regulatory consultants with expertise in this area
• Researchers or clinicians with an interest in assessment of proarrhythmia

TOPICS

• Background, Motivation for and Overview of the New Q&As for ICH E14 and S7B
• Revised E14 Q&As and Presentation of Examples to Highlight the Impact of Nonclinical Data on Clinical Development and Interpretation
• S7B Integrated Risk Assessment Q&As
• Considerations for an Integrated Nonclinical-Clinical Risk Assessment
• Best Practice Considerations for In vitro Studies Q&As
• Best Practice Considerations for In vivo QT Studies Q&As
• Principles of Proarrhythmia Models Q&As
• Discuss Clarifying Questions Received during the Webinar

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and regular updates for regulated industry such as:

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• CDERSBIA@fda.hhs.gov | 1-866-405-5367 | (301) 796-6707

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