Webinars

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

December 11, 2024

ICH S1B(R1): US Regulatory Perspectives on the New Weight of Evidence Approach

Advanced

Emerging 

Speakers:

Timothy McGovern

Todd Bourcier

The S1BR1 addendum expanded the evaluation process for assessing the human carcinogenic risk of pharmaceuticals. The addendum introduced a weight-of-evidence (WoE) approach to determine if a two-year rat study would add value to an assessment based on an integrated review of drug target pharmacology and compound-specific toxicology. Successful implementation of this approach would ideally shift focus toward more mechanism-based carcinogenicity assessments and reduce the use of animals, while continuing to promote the safe development of new pharmaceuticals. To support successful implementation, the FDA arranged a review forum comprised of key review staff and members of the Executive Carcinogenicity Assessment Committee to discuss and provide recommendations on sponsors’ WoE submissions. This approach increases familiarity with these submissions, fosters consistency in review and regulatory decision making, and allows for tracking decisions and lessons learned from each submission. Initial experience with S1BR1 WoE submissions indicates that concordance with the sponsor’s assessments is reasonably consistent with expectations from the prospective evaluation study which supported implementation of the addendum. Sponsor submissions have varied in quality and completeness. This session will provide an overview of the WoE approach described in the ICH S1B Addendum and summarize initial experience with implementation including key strengths and deficiencies of the WoE submissions.

Watch the Webinar

 

Coming in 2025*

*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.

ACT Member On-Demand Webinars

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
(View library
)

Emerging
New, unusual, or uncommon techniques, modalities, ROA, guidance, tools/equipment (hardware and software), and/or changes to standard practice
(View library
)

TOP