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Carcinogenicity

Tomorrow’s Data, Today


Description
Welcome to the NURA course Tomorrow’s Data, Today: Sunsetting the 2-year Carcinogenicity Assay.

There is a growing consensus among experts that the current carcinogenicity assessment paradigm needs to shift from the traditional 2-year rodent “bioassay” to a more predictive, human-relevant carcinogenicity assessment. This course features international experts from regulatory, industry, and academic backgrounds working to achieve that goal.

In this training course, hear directly from experts covering current progress among working groups, AOPs and IATAs, case studies, and promising technologies to use in weight-of-evidence carcinogenicity assessments.

In this introduction video, Eryn Slankster-Schmierer, PhD, Physicians Committee for Responsible Medicine, presents the regulatory context for carcinogenicity testing.

Speakers:
Eryn Slankster-Schmierer, PhD, Physicians Committee for Responsible Medicine, Moderator
Tim McGovern, PhD, CDER, US FDA
Joseph Manuppello, Physicians Committee for Responsible Medicine
Connie Mitchell, MS, HESI Workgroup
Gina Hilton, PhD, PSCI
Sarah Dobreniecki, PhD, OPP, US EPA
Susanne Stalford, PhD, Lhasa Ltd
Mirjam Luijten, PhD, RIVM, EPAA Workgroup
Chris Corton, PhD, ORD, US EPA
Annamaria Colacci, PhD, University of Bologna
Ting Li, PhD, NCTR, FDA
Carole Yauk, PhD, University of Ottawa

Content
  • Introduction
  • ICH S1B(R1): A New Weight of Evidence Approach
  • Animal use and opportunities for reduction in pharmaceuticals testing
  • Transcriptomic Biomarker for Genotoxicity Hazard Assessment
  • Tomorrow’s Data, Today - Session 1 Panel Discussion
  • Tomorrow's Data, Today Session 2 Introduction
  • Achieving a new approach to carcinogenicity assessment for agrochemicals
  • Weight-of-evidence Approach for Waiving Long-term Rodent Bioassays
  • Using Adverse Outcome Pathways as a Framework for Carcinogenicity Assessment
  • WOE Approach to Carcinogenicity Assessment of Agrochemicals
  • Tomorrow's Data, Today - Session 2 Panel Discussion
  • Tomorrow's Data, Today - Session 3 Introduction
  • Using Transcript Profiling to Identify Carcinogens
  • The Transformics Assay: An Integrated Approach
  • DeepCarc: Deep Learning-powered Carcinogenicity Prediction
  • Toxicogenomics in Action: Case Studies
  • Tomorrow's Data, Today Session 3 Panel Discussion
  • Course Survey, Tomorrow's Data Today
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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