- October 15 - 16, 2020
- - ET
- - ET
Presentation and Discussion from the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group on the Recently Released Draft Q&As to ICH E14 and S7B
This webinar will be presented by multiple regulatory and industry members from 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.
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.
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.
- Drug development professionals and stakeholders with an interest in understanding the potential impact of the draft Q&As
- 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
- 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
New Questions & Answers to ICH E14 and S7B
- Working Group Webpage
- E14/S7B Draft Q&As (Aug 2020)
- E14/S7B Work Plan (Apr 2020)
- E14/S7B Concept Paper (Nov 2018)
Original ICH E14 and S7B Guidelines and Existing E14 Q&As
Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:
- has been pre-approved by RAPS as eligible for up to 4 credits towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
Please contact email@example.com for all technical questions.
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