| 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
| Webinar 1
3rd November 2026
10am – 12pm |
INTRODUCTION TO REGULATORY TOXICOLOGY
Overview of regulatory toxicology, its aims and purpose.
Overview of hazard and risk assessment, including classification and labelling.
Summary of the current situation and potential future changes in regard to animal testing and NAMs.
Speakers:
Charlotte Thorpe, HSE
Dr Susy Brescia, HSE
Amy Marriott, NC3Rs |
| Webinar 2
11th November 2026
10am – 12pm |
ACUTE TOXICITY, IRRITATION & SENSITISATION
Acute oral and dermal toxicity studies.
Acute inhalation toxicity.
Irritation & sensitisation studies.
Speakers:
Hayley Parker, Labcorp
Dr Jo Kilgour, Mereside Toxicology Consulting
Emma Moore, Labcorp
Peter Rees, Labcorp |
| Webinar 3
20th November 2026
10am – 12pm |
GENOTOXICITY
Genotoxicity studies: introduction, general principles.
The use of (Q)SAR as a predictor of genotoxicity.
Mechanisms of genotoxicity, implications for risk assessment.
Speakers:
Dr Katherine Chapman, Swansea University
Dr Alex Cayley, Independent
Dr Paul Fowler, FSTox Consulting |
| Webinar 4
24th November 2026
10am – 12pm |
DART & Endocrine Disruptors
Introduction to developmental and reproductive toxicology studies
Overview of endocrine disruption
Use (and potential future use) of NAMs in repeated dose toxicity and DART.
Speakers:
Dr Hollie Blunt, Sequani
Dr Jason Manton, Toxiqua
Dr Matthew Dent, Unilever |
| Webinar 5
25th November 2026
10am – 12pm |
ADME / TOXICOKINETICS
Overview of ADME / toxicokinetics.`
Overview of in vitro methods of metabolism & absorption.
Introduction to PBPK modelling.
Speakers:
Alex Gledhill, ERM
Katherine Knowles, Syngenta
Dr Ciarán Fisher, GSK |
| Webinar 6
4th December 2026
10am – 12pm |
REPEATED DOSE TOXICITY & CARCINOGENICITY
Repeated dose toxicity: general principles.
Carcinogenicity studies.
Pathological findings.
Speakers:
Dr Meera Cush, Ramboll
Helen-Marie Dunmore, Certara
Dr Davide Corbetta, CRL |
| In-person event
Date TBC but will be in early 2027 |
Regulatory case studies |
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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
This module will consider WoE approaches in safety assessment to support the integration of NAM data into decision making processes.
REGISTRATION OPEN
Date Module Offered.
Webinars: September/October 2026
Workshops will be on the 23rd and 24th November 2026 in Leeds. Venue TBC.
Learning Aims.
The aim of this module is to equip delegates to clearly and systemically frame the scientific question to be addressed using a WoE, to conduct WoE assessments and to identify, select and appropriately integrate relevant data sources, with a particular focus on New Approach Methodologies (NAMs) and Next Generation Risk Assessment (NGRA) approaches, to address questions raised within a safety assessment.
This module will focus on assessing the most appropriate approaches to answer the scientific question, and systematically analyse, assemble, weigh and integrate diverse data types to derive conclusions moving beyond referring to standard data requirements.
The webinars will consist of lectures and discussion sessions. The lectures within each of the key areas will cover frameworks, criteria for evaluating data reliability and relevance, and methods for integrating evidence, including qualitative, semi-quantitative, and quantitative approaches.
Delegates will gain an understanding of how WoE approaches can be applied across a number of different regulated sectors including for example personal care products, pharmaceuticals and agrochemicals. The module concludes with in-person workshops featuring real-world examples from these sectors, enabling delegates to identify when WoE may be used and select appropriate data sources, and confidently integrate NAMs and traditional toxicology data (where appropriate) into scientifically robust safety assessments.
- Understand the relevance of different data streams to the decision that needs to be made.
- Understand how to differentiate between high and low-quality studies (scoring/ranking).
- Apply structured approaches rather than ad-hoc, subjective judgments.
- Effectively integrate different types of scientific information, including divergent data.
- Understand similarities/commonalities and differences in WoE approaches applied across different sectors such as personal care products, agrochemicals and pharmaceuticals.
- Understand similarities/commonalities and differences in WoE approaches applied across different regulators such as FSA,OPSS,MHRA,EMA,EFSA,FDA and ICH.
Module Content
Webinar 1: The foundations of chemical safety assessment and NAMs.
Wednesday September 23rd: 10:00-12:00 (UK)
- Lecture 1 – Introduction to Safety Assessment and Regulatory Context (Hazard vs. Risk, REACH,FSA/MRHA/EMA/EFSA/EPA/FDA context).
- Speaker: Dr Jay Ingram, Director, Chemicals at Humane World for Animals, Milton Ernest, United Kingdom.
Aims
- To introduce delegates to the fundamental risk assessment principles, distinguishing between hazard (potential to cause harm) and risk (likelihood of harm).
- To provide delegates with a foundational understanding of the regulatory frameworks that use these concepts to protect human and environmental health such as:
- HSE/ECHA/EPA for REACH for equivalent regulations for chemicals
- MHRA/EMA/FDA for Pharmaceuticals
- OPSS/SCCS/FDA for Cosmetics
- FSA/EFSA/EPA for food/environmental safety
- Lecture 2 – Traditional Toxicology, NAMs and prospects for Artificial Intelligence.
- Speaker: Adrian Fowkes, Director of Science at Lhasa Limited
Aims
- To allow delegates an opportunity to review the strengths and weaknesses of traditional in vivo toxicity data, highlighting its regulatory history, scientific limitations, and data provided from these studies.
- To provide delegates the opportunity to discuss the principles of NAMs.
- To briefly introduce delegates to the use of Artificial Intelligence (AI) as a critical future enabler for NAMs in supporting assessment of chemical safety.
- Lecture 3 – Exposure-Based Assessment and Next Generation Risk Assessment (NGRA).
- Speaker: Dr Matthew Dent, Unilever, Bedfordshire, UK.
Aims
- To equip delegates with the knowledge to support the transition from traditional hazard-focused, animal-based testing to modernised, non-animal, exposure-led, and risk-based approaches.
- To provide delegates with an opportunity to discuss the pros and cons of this transition to evaluate chemical safety focusing on human-relevant exposure scenarios, ensuring human health protection.
Webinar 2 The principles and frameworks of the WoE approach and data gathering.
Wednesday September 30th: 10:00-12:00 (UK)
- Lecture 1 – Introduction to the Principles of WoE and its application.
- Speaker: Dr Fiona Sewell, NC3Rs, London, UK.
Aims:
- To ensure delegates have an opportunity to consider the potential 3Rs benefits through application of WoE assessment.
- To provide delegates an opportunity to explore the role of WoE in chemical, pharmaceutical, cosmetics, food and environmental hazard evaluation and risk assessment.
- To provide delegates with an understanding of when to apply WoE (e.g.: when multiple, conflicting sources are available).
- Lecture 2 – Evaluating Evidence (Relevance, Reliability, Consistency).
- Speaker: Dr Patience Browne Head of the Hazard Assessment and Exposure Assessment Programmes, Environment, Health and Safety Division, Environment Directorate OECD, Paris, France.
Aim:
- To provide delegates with a brief outline to the three basic steps of WoE namely:
- Problem formulation / Framing the scientific question or decision-context: Understanding the scientific decision that needs to be made
- Assembling the Evidence: Strategies for identifying and collecting relevant data (toxicological, epidemiological, in vitro, in silico).
- Reliability and Relevance of the Evidence: Assessing the quality of content and consistency.
- Integrating Evidence: Combining weighted evidence to reach a final conclusion.
- Lecture 3 – Integrating NAMs into Regulatory Frameworks.
- Speaker: TBC
Aims
- To demonstrate to delegates how NAMs are used for identifying, prioritising, or filling data gaps for chemical risk assessments.
- To demonstrate to delegates how the data assembly process must be systematic to ensure transparency.
Webinar 3: Sourcing and assembling diverse evidence streams.
Thursday October 8th : 10:00-12:00 (UK)
- Lecture 1 – Sourcing Diverse Evidence Streams.
- Speaker: Dr Camilla Alexander-White, MKTox Consultancy, UK.
Aim
To demonstrate to delegates how WoE requires collecting evidence from multiple, independent lines of evidence to reduce bias and handle data gaps. Examples of this in practice.
- Lecture 2 – Handling Uncertainty.
- Speaker: Dr Jean Lou Dorne Senior Scientific Officer in Toxicology and Lead Expert in New Approach Methodologies European Food Safety Authority (EFSA),Parma, Italy.
Aims
- To enable delegates to be able to identify and describe uncertainties in the WoE process.
- To demonstrate to delegates the critical part of the WoE in assessing uncertainty associated with NAM data and determining if this is sufficiently low to enable reliable decision making.
- Round Table Discussion.
Aim
To provide delegates an opportunity to discuss the principles and frameworks of the WoE approach, data reliability and limitations of this data.
Webinar 4: Qualitative and quantitative methods for evidence integration.
Wednesday October 15th: 10:00-12:00 (UK)
- Lecture 1 – Qualitative Approaches.
- Speaker: Professor Alan Boobis, Imperial College, London, UK.
Aims
- To provide delegates an introduction to how integrating NAMs into WoE for risk assessment utilises qualitative data.
- To provide delegates an insight into different approaches combining diverse data streams like in vitro assays, in silico modelling, and -omics
- To provide delegates with an introduction to on how to organise information from these approaches, for example using frameworks such as Adverse Outcome Pathways (AOPs).
- Lecture 2 – Quantitative Approaches.
- Speaker: Professor Alan Boobis, Imperial College, London, UK.
Aims
- To provide delegates an introduction to how integrating NAMs into WoE for risk assessment utilizes quantitative data.
- To provide delegates with an introduction to some of these approaches including Scoring and Ranking Systems, Bayesian Networks and Indexing and Empirical Methods.
- To allow delegates to be aware how these methods ensure that both subjective expert knowledge and objective, data-driven insights are incorporated into the risk assessment process.
- To demonstrate to delegates criteria-based methodologies for determining cause-and-effect relationships.
- To provide delegates with an opportunity to explore Integrated Approaches to Testing and Assessment (IATA) and Defined Approaches (DA) which represent frameworks used to integrate diverse data sources for regulatory decisions.
- To provide delegates an opportunity to explore how the Weight of Evidence (WoE) evaluation is a systematic, often semi-quantitative, process considering how . AOPs can help structure and increase confidence in biologically plausible linkages demonstrated/inferred by the data
- Lecture 3 – Visualizations and Integration Tools.
- Speaker: TBC
Aims
- To provide delegates an introduction to how integrating NAMs into WoE for risk assessment utilizes integrated tools.
- To provide delegates with an introduction to some of these approaches including heat maps as an example.
- To allow delegates to be aware how these methods ensure that both subjective expert knowledge and objective, data-driven insights are incorporated into the risk assessment process.
Webinar 5: Regulatory reporting and the acceptance of WoE/NAMs-based assessments.
Wednesday October 22nd: 10:00-12:00 (UK)
- Lecture 1 – WoE and the integration of NAMs-Government Initiatives.
- Speaker: Dr Natalie Burden, NC3Rs, London, UK.
Aims
- To remind delegates that this approach needs a structured, scientific, and trust-building strategy focusing on human relevance, transparency, and validation.
- To emphasise to delegates that NAMs and WoE need to provide equal or greater predictive confidence than traditional animal testing, using case studies to demonstrate practical, actionable compliance.
- Current Government Initiatives
- Lecture 2 – Roadmaps to the acceptance of NAMs in WoE assessments.
- Speaker: Dr Olivia Osborne, FSA, London, UK.
Aim
- To provide delegates with some examples of guidance and Road Maps such as:
- EMA Road Map (Real-World Evidence (RWE)) which is designed to advance the use of real-world data (RWD) for regulatory decisions, transforming it from “supportive” to “decision-critical”
- EFSA Guidance of WoE (Scientific Assessments) which provides a comprehensive approach involving problem formulation, data collection, and methodological steps for integrating qualitative and quantitative lines of evidence.
- UK COT Road Map illustrates a 7-step roadmap designed for NAMs in chemical risk assessment to gain acceptance and integration.
Aims
- Delegates will be encouraged to discuss how NAM data successfully supports key regulatory decisions using real-world or mock scenarios.
- Delegates will be encouraged to proactively discuss the limitations and uncertainties of using the NAM data compared to traditional test data.
In-person Workshops
Dates:
- 23rd November 2026 – Workshop 1
- 24th November 2026 – Workshop 2
Location:
Venue:
Introduction
Workshops using real world data will provide delegates the opportunity to apply the knowledge gained during the webinar series together with their own experiences to discuss how application of NAM data aims to accelerate the transition away from traditional animal testing by building scientific confidence, establishing regulatory frameworks, and fostering cross-sector collaboration. The case studies will be taken from a number of sectors.
The key goals include:
- Review of the processes available for regulatory approval and the timelines to regulatory acceptance
- How scientific validity of methods is assured
- What and how practical skills in new technologies are being developed.
- Considering Best Practice and Common Challenges.
- Limitations of the WoE approach.
Workshops
The Workshop will cover practical application and case studies. Delegates will consider several concepts such as NAM-enhanced read-across.
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.
In this workshop there will be an opportunity to have a round table discussion to acknowledge / link uncertainty handling to regulatory confidence and decision thresholds which are considered one of the major barriers to acceptance.
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