| Core Module 1 (repeat) – An introduction to the principles of regulatory toxicology: present and future |
|
| 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 moron 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 |
|
| Core Module 3 (Repeat) – Genetic Toxicology |
|
| 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: June-July 2026 (tbc)
| Webinar 1 |
An introduction to genetic toxicology testing; overview of in vitro models |
| Webinar 2 |
Overview of in vivo testing models and genetic toxicity data analysis |
| Webinar 3 |
Advances in genetic toxicology risk assessment |
| Webinar 4 |
Regulatory case studies in genetic toxicology (1) |
| Webinar 4 |
Regulatory case studies in genetic toxicology (2) |
|
| Core Module 6 – Carcinogenicity |
|
| 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: May 2026 (tbc)
| Webinar 1 |
Assessment of carcinogenicity – requirements under agrochemical regulations. Hazard classification (CLP) |
| Webinar 2 |
Assessment of carcinogenicity – requirements under pharmaceutical regulations (US FDA, EMA); ICH S1B WoE approach |
| Webinar 3 |
Carcinogenicity study design, including factors influencing dose selection |
| Webinar 4 |
An introduction to pathology assessment in carcinogenicity studies |
| Webinar 5 |
An introduction to statistical methods used in carcinogenicity studies |
| Webinar 6 |
Using NAMs in the assessment of carcinogenicity |
|
| Core Module 7 – Inhalation toxicology |
|
|
| 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 |
|
| 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 |
|
| Core Module 9: Endocrine Disruption (Introductory) |
|
- 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: April-May 2026 (tbc)
| 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. |
|