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BTS Skills Gap training modules

The draft timetable for the BTS Skills Gap Initiative training modules planned for 2026 is shown below.

Webinar sessions are typically two hours long, including a Q&A session. Some modules include in-person events, which will be held at a central location and hosted by experienced regulatory toxicologist or subject matter experts. All modules will be delivered by recognised experts from industry, academia or government departments. The cost of registration for each module is £275. Registrants will have access to webinar recordings and training material; a certificate of attendance will be provided on completion of a module.

Please note that timings and content detail may be subject to change. Some modules may have a registration limit, and also require a minimum number of participants to go ahead.

Module details will be updated and registration will be opened in early 2026.

For further information, please contact meetings@thebts.org

REGISTER HERE – https://execbs.eventsair.com/bts-skills-gap-modules-2026/skills-gap-initiative-modules2026

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 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

Core Module 3 (Repeat) – Genetic Toxicology – REGISTRATION OPEN

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: July 6th-8th 2026

Webinar 1

Monday 6th July 2026

10am – 12pm

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

Speakers:

Kate Chapman (Swansea University)

Zofi McKenzie (Syngenta)

Webinar 2

Monday 6th July 2026

1pm – 3pm

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

Speaker: Paul Fowler (FSTox Consulting)

Webinar 3

Tuesday 7th July 2026

10am – 12pm

Advances in genetic toxicity risk assessment methods and regulation

Development of the gH2AX/pH3 assay and its OECD validation

Speaker: Marc Audebert (INRAE ToxAlim)

Genetic toxicology of nanoparticles

Speaker: Mike Burgum (Swansea University)

NAM example: ToxTracker and MutaTracker assays

Speaker: Inger Brandsma (Toxys)

NAM example: Applying error-corrected Next Generation Sequencing to genetic toxicology safety assessment

Speaker: Sujath Abbas (GSK)

Webinar 4

Wednesday 8th July 2026

10am – 12pm

Regulatory perspectives: Case studies

Pharmaceuticals industry with a focus on high throughput models

Speaker: Amy Wilson (AstraZeneca)

Agrochemicals industry

Speaker: Carol Beevers (Corteva)

In silico (QSAR) assessment with a focus on nitrosamines

Speaker: Ben Thornton (Lhasa Ltd)

Cosmetics industry

Speaker: Georgia Morgan (ISCA Cosmetics)

Webinar 5

Wednesday 8th July 2026

1pm – 2pm

Regulatory perspectives: Case studies

Regulatory decision-making around pharmacogenomics

Speaker: Eileen Gallagher (MHRA)

Embracing regulatory compliance: Genetox meets Generation SEND

Speaker: Frances Hall (Instem)

Module summary

Speaker: Kate Chapman (Swansea University)

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

Core Module 7 – Inhalation toxicology – REGISTRATION OPEN

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: September/October 2026 (tbc)

Event	Topic
Webinar 1	1. Introduction 2. Anatomy and physiology of the respiratory tract 3. Animal species and humans. Regulatory approaches and lack of harmonisation
Webinar 2	1. Pharmaceutical – dose calculation 2. Chemicals/agrochemicals 3. Other areas, Human data extrapolation
Webinar 3	1. e-cigarettes 2. nano particles / fibres 3. Environmental
Webinar 4	1. Animal welfare initiatives, reduction and refinement opportunities 2. The current and future use of NAMs in inhalation toxicology 3. Government roadmaps to replacement
Webinar 5	1. New approaches 2. Validation and regulatory adoption of new approaches
In-person event	Equipment demonstration / hands-on experience Problem solving

Core Module 8: Neurotoxicology – REGISTRATION OPEN

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: October/November 2026 (tbc)

Webinar 1	Introduction to the human nervous system and neurotoxicity The CNS and PNS, structure and function Mechanisms of neurotoxicity
Webinar 2	Introduction to the developing human brain Structure and function and importance of timing; proliferation, migration, differentiation (neuronal and glia), neurite outgrowth, synaptogenesis, apoptosis (pruning), network formation. Endocrine impact Developmental neurotoxicity Mechanisms of developmental neurotoxicity with examples
Webinar 3	Regulatory assessment of neurotoxicity Animals as models; comparison of brain development Animal behaviour and neurophysiological tests. Neurochemistry Neuropathology
Webinar 4	The use of NAMS in developmental neurotoxicity assessment The history of the DNT-IVB Filling uncertainties in the DNT-IVB part 1: Cell-based approaches Filling uncertainties in the DNT-IVB part 1: Behaviour-based approaches Anchoring cell- and zebrafish-based DNT NAM effect concentrations to human blood concentrations
Webinar 5	The use of NAMS in neurotoxicity assessment Multielectrode arrays and ion channels for drug safety assessment Research methods for Acute Neurotoxicity – in vitro and ex vivo techniques Use of in vitro data alongside historical in vivo data to use as read across analogues and/or use as potency comparisons for human toxicity estimates.

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

REGISTRATION OPEN

Aims

This module will consider WoE approaches in safety assessment to support the integration of NAM data into decision making processes.

Date Module Offered.

Webinars: September/October 2026

Workshops 10^th and 11^th November 2026 and repeated the 25^th and 26^th November 2026.

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.

Key Learning Outcomes.

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 23^rd: 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).

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.

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).

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 30^th: 10:00-12:00 (UK)

Lecture 1

Introduction to the Principles of WoE and its application.

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).

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.

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 8^th : 10:00-12:00 (UK)

Lecture 1

Sourcing Diverse Evidence Streams.

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.

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 14^th: 10:00-12:00 (UK)

Lecture 1

Qualitative Approaches.

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.

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.

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 21^st: 10:00-12:00 (UK)

Lecture 1

WoE and the integration of NAMs-Government Initiatives.

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.

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.

Case Studies.

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

- Logistics

Dates:

10^th November 2026 Workshop 1
11^th November 2026 Workshop 2

Workshops will be repeated depending on numbers and the dates are;

25th November 2026 Workshop 1
26^th November 2026 Workshop 2

Location:

London

Venue:

To be confirmed

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

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.

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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