ICH E14 and S7B: Webinar on the Recently Released Draft Q&As

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment

 

October 15 and 16, 2020 – 8:00-10:00 am US EDT

Registration Link   |   Agenda Link

This free two-day public webinar hosted by FDA will be presented by multiple regulatory and industry members from around the world that are members of the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group on the Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential. This working group developed new Questions & Answers (Q&As) to ICH E14 and S7B, which were released by ICH as a Draft Guideline for public consultation on August 27, 2020.

The webinar will cover the background, motivation for, and overview of the new Q&As for ICH E14/S7B, followed by presentations on each of the main Q&A topics. Example cases will be presented that highlight the potential impact of applying the principles in the new Q&As on drug development and regulatory evaluation. Questions can be submitted via the Q&A pod during the webinar. Submitted questions will be discussed at the end of each of the two sessions by members of the E14/S7B working group.

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, and in later stages of clinical development as a part of a combined nonclinical-clinical integrated risk assessment. If implemented, they can lead to a reduction in the number of ‘Thorough QT’ clinical studies and improved decision making at the time of a marketing application.

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
  • Drug development professionals and stakeholders with an interest in understanding the potential impact of the draft Q&As

Dates/Times AND TOPICS

  • Tuesday, October 15, 2020 – 8:00-10:30 am US EDT (UTC/GMT -4 hours)
    • 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
    • Discuss Questions Received during the Webinar

 

  • Wednesday, October 16, 2020 – 8:00-10:30 am US EDT (UTC/GMT -4 hours)
    • Day 1 Recap and Introduction to Technical S7B Q&As
    • 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 Questions Received during the Webinar

RESOURCES 

New Questions & Answers to ICH E14 and S7B

Original ICH E14 and S7B Guidelines and Existing E14 Q&As

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