ACT Signature Webinar series provides accessible education to members of the toxicology community worldwide. These educational webinars cover current topics in toxicology and are presented by experts in the field, with backgrounds in government, industry, or academia.
The live Signature Webinars are held on a quarterly basis and are free to both ACT members and nonmembers. Each webinar is approximately 90 minutes, followed by a 30-minute questions and answers session with the speaker(s).
After the live webinar, nonmembers may purchase on-demand access of the webinar for a fee. On-demand access of the webinar allows for viewing for seven days. ACT members may continue viewing the on-demand webinar without a fee. Fees are accessed according to the membership status at the time of purchase and there are no refunds.
Signature Webinar
June 11, 2025, 11:30 AM–1:00 PM Eastern
Implementing ICH E14/S7B Q&As and Applying Nonclinical Data for Integrated QTc Prolongation Risk Assessment and Requesting a Clinical TQT Alternative
Speaker:
ICH E14/S7B Q&As adopted in 2022 allow for an integrated risk assessment using nonclinical in vitro and in vivo data, together with results from early clinical trials, to inform the design of clinical investigations and interpretation of QTc-related findings. Specifically, adequate and satisfactory nonclinical data may qualify as a “double-negative” and be used with supporting clinical results to potentially avoid the need for a dedicated clinical thorough QT study with a positive control drug. This presentation will highlight features of the Q&As, including best practices for nonclinical studies, and summarize case examples where this approach has been implemented within our organization. Overarching themes and learnings will also be reviewed.
On-Demand Access
On-demand Signature webinars are available for free to ACT members and $50 for nonmembers. Purchasing of the on-demand webinar provides unlimited viewing for seven days. Viewing is restricted to a single user only. Webinars are approximately 90 minutes with up to 30 minutes of audience questions and speaker answers. There are no cancelations or refunds allowed after the payment has been processed.
The following learning levels have been identified for ACT educational offerings.
Foundational (Basic)
Focuses on core skills or fundamental understanding of a topic (View library )
Advanced
The converse of basic, if not basic then advanced (View library )
Practical
How to do it—procedures, design, reporting, use of tools, tips, tricks, experiences, and/or advice
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Emerging
New, unusual, or uncommon techniques, modalities, ROA, guidance, tools/equipment (hardware and software), and/or changes to standard practice
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