| Core Module 1 (repeat) – An introduction to the principles of regulatory toxicology: present and future |
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| This introductory module is intended to provide a general overview of regulatory toxicology to those in an early stage of their careers, or more experienced toxicologists interested in learning more about regulatory toxicology. The module covers the types of data typically encountered by a regulatory toxicologist as well as the potential regulatory use of NAMs. The module concludes with an in-person Workshop in which delegates will work in small groups, guided by experienced facilitators, with more on the assessment of real case studies in regulatory toxicology.
Date: November-December 2026 (tbc)
| Webinar 1 |
An introduction to regulatory toxicology; hazard and risk assessment; the current and future use of NAMs |
| Webinar 2 |
Acute oral, dermal and inhalation toxicity; irritation and sensitization testing |
| Webinar 3 |
Toxicokinetics: an overview of toxicokinetics/ADME; overview of in vitro methods of metabolism & absorption; Introduction to PBPK modelling |
| Webinar 4 |
Genetic Toxicology: introduction and general principles of genetic toxicology; the use of (Q)SAR as a predictor of genotoxicity; mechanisms of genotoxicity, implications for risk assessment |
| Webinar 5 |
Repeated dose toxicity and carcinogenicity; an introduction to pathology assessment |
| Webinar 6 |
DART and endocrine disruptors: Developmental toxicity studies; overview of endocrine disruption; use (and potential future use) of NAMs in repeated dose toxicity and DART |
| In-person event |
Regulatory case studies |
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| Core Module 3 (Repeat) – Genetic Toxicology – REGISTRATION OPEN |
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| The aim of this module, which is coordinated by Swansea University, covers the critical area of genetic toxicology. The module covers the background and mechanisms of genetic toxicology, study types, advances in the field, and the use and interpretation of genetic toxicology data in a regulatory context.
Date: W/C July 6th 2026
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| Webinar 1 |
Introduction to the module and in vitro testing models |
| -The modes of action of genotoxic agents, and how they can contribute to cancer and inversely be used as chemotherapeutics
-Current overarching themes in the genotoxicity field (e.g., high throughput, multiple endpoint testing)
-In vitro assays with OECD guidelines and new developments in this area
-Introduction to the 3Rs in toxicology research and testing |
| Webinar 2 |
In vivo testing models and genetic toxicity data analysis |
| -In vivo assays with OECD guidelines and potential future techniques
-Quantitative and qualitative assessment of genotoxic data
-Hazard and risk assessment |
| Webinar 3 |
Advances in genetic toxicity risk assessment methods and regulation |
| Development of the gH2AX/pH3 assay and its OECD validation |
| Genetic toxicology of nanoparticles |
| NAM example: ToxTracker and MutaTracker assays |
| NAM example: Applying error-corrected Next Generation Sequencing to genetic toxicology safety assessment |
| Webinar 4 |
Regulatory perspectives: Case studies |
| Pharmaceuticals industry with a focus on high throughput models |
| Agrochemicals industry |
| In silico (QSAR) assessment with a focus on nitrosamines |
| Cosmetics industry |
| Webinar 5 |
Regulatory perspectives: Case studies |
| Regulatory decision-making around pharmacogenomics |
| Embracing regulatory compliance: Genetox meets Generation SEND |
| Module summary |
Core Module 6 – Carcinogenicity – REGISTRATION OPEN
The module covers the requirements for carcinogenicity testing under different regulated sectors, and includes pathological and statistical aspects, as well as the current and potential use of NAMs in carcinogenicity testing
Date: W/C 18th May 2026
| Format |
Topics |
| Webinar 1
18th May 2026
9am – 11am |
Carcinogenicity study design, dose selection
Speaker: Joffrey Ducroq, Charles River Laboratories |
| Webinar 2
19th May 2026
10am-12pm |
Agrochemical regulations, Classification (CLP), Case study
Speaker: Stephanie Melching-Kollmuss, BASF |
| Pharmaceutical regulations (US FDA, EMA), ICH S1B WoE approach
Speaker: Helen-Marie Dunmore, Certara |
| Webinar 3
20th May 2026
10am – 11am |
Introduction to pathology assessment in carcinogenicity studies
Speaker: Davide Corbetta, Charles River Laboratories |
| Webinar 4
21st May 2026
10am – 11am |
Introduction to statistical assessment in carcinogenicity studies
Speaker: Jim Saul, LabCorp |
| Webinar 5
11th June 2026
10am – 12pm |
Using NAMs in the assessment of carcinogenicity
Speakers: Mark Cronin, Liverpool John Moores University and Rhiannon David, AstraZeneca |
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| Core Module 7 – Inhalation toxicology |
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| The aim of this module is to provide an overview of the role of inhalation toxicology in a regulatory context, including the current and future use of NAMs. The module concludes with an in-person event held at an inhalation toxicity testing facility.
Date: May-July 2026 (tbc)
| Webinar 1 |
An introduction to inhalation toxicology; the anatomy and physiology of the respiratory tract; in vivo models and human relevance; regulatory approaches. |
| Webinar 2 |
Regulatory requirements for inhalation toxicology across different sectors (pharmaceuticals, agrochemicals, chemicals, defence) |
| Webinar 3 |
Inhalation toxicology in other settings (e-cigarettes, nanoparticles, environmental pollution) |
| Webinar 4 |
Good practice; animal welfare initiatives; incorporating the 3Rs into inhalation toxicology study design; the importance of good practice for good data |
| Webinar 5 |
The future of inhalation toxicology, including the use of NAMs |
| In-person event |
CRO visit; hands-on experience, equipment demonstration and problem solving |
Core Module 8: Neurotoxicology
The aim of this module is to provide an overview of the role of neurotoxicology, including the current and potential future use of NAMs.
Date: November 2026 (tbc) |
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| Webinar 1 |
An introduction to the human nervous system, mechanisms of neurotoxicity |
| Webinar 2 |
The developing human brain, mechanisms of developmental neurotoxicity |
| Webinar 3 |
Assessment of neurotoxicology using the intact nervous system: human tests and in vivo models |
| Webinar 4 |
Assessment of neurotoxicology using the intact nervous system: ex vivo and in vitro models |
| Webinar 5 |
The use of NAMs in developmental neurotoxicity assessment |
| Webinar 6 |
The use of NAMs in neurotoxicity assessment |
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Core Module 9: Endocrine Disruption (Introductory) |
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| This module provides an introduction to the regulatory assessment of endocrine disrupting chemicals for human health and environmental effects. Topics include study types, the integration of in silico, in vitro and in vivo data required for weight of evidence assessment and mode of action analysis.
Date: November-December 2026 (tbc)
| Webinar 1 |
Overview of the endocrine system; an introduction to endocrine disruption by chemicals; effects on human health; environmental effects; regulatory implications; hazard classification (CLP) |
| Webinar 2 |
Assessment of endocrine disruption using test methods for effects on human health |
| Webinar 3 |
Assessment of endocrine disruption using test methods for effects on the environment |
| Webinar 4 |
Assessment of the endocrine-disrupting potential of chemicals using a weight of evidence approach |
| Webinar 5 |
Mode of action analysis for endocrine-disrupting chemicals |
| Webinar 6 |
Regulatory case studies in endocrine disruption; |
Supplementary Module 3: Weight of Evidence Approaches in Safety Assessment
The aim of this module is to equip participants to conduct weight-of-evidence (WoE) assessments and identify which data sources, focussing on New Approach Methodologies (NAMs) and Next Generation Risk Assessment (NGRA) approaches, can be used to address questions raised within a safety assessment. Participants will gain an understanding of how WoE approaches can be applied across a number of different regulated sectors. The module concludes with an in-person workshop featuring real-world examples from these sectors, enabling participants to confidently integrate NAMs and traditional toxicology data into scientifically robust safety assessments.
Date: September/October 2026 (tbc) – Workshop in November 2026
| Webinar 1 |
The foundations of chemical safety assessment and NAMs |
| Webinar 2 |
The principles and frameworks of the WoE approach |
| Webinar 3 |
Sourcing and assembling diverse evidence streams |
| Webinar 4 |
Qualitative and quantitative methods for evidence integration |
| Webinar 5 |
Regulatory reporting and the acceptance of WoE/NAMS assessments |
| Workshop 1 |
The Workshop will cover practical application and case studies. Delegates will consider several concepts such as NAM-enhanced read-across. |
| Workshop 2 |
During this Workshop, delegates will consider how to assess the evidence and apply the WoE framework to real-world scenarios, decision-making processes, and case studies that explain the potential decision process. Delegates will also have the opportunity to discuss building/establishing integrated/WoE evidence-based approaches as new methods emerge. |
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