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NC3Rs | 20 Years: Pioneering Better Science

Increasing confidence in New Approach Methodologies for regulatory decision-making


Registration Details

Event date and time
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In collaboration with the British Toxicology Society and the Health and Safety Executive’s Chemicals Regulation Division, the NC3Rs is hosting a two-day virtual workshop on 23-24 February 2022. The workshop will be chaired by Professor John Colbourne, University of Birmingham and Professor Alan Boobis, Imperial College London.

New approach methodologies (NAMs) have great promise in providing useful information for chemical hazard and risk assessment.  In the last decade, significant investment has been made in developing new tools that can reduce reliance on animals and improve decision-making in chemical safety assessments, including computational models, read-across and grouping approaches, microphysiological systems and ‘omics’ technologies.  However, there is often a lack of confidence in applying these methods within a regulatory setting, and uptake for hazard identification and characterisation of complex endpoints requires further development.  A focus on methods that provide a better understanding of mechanisms behind adverse effects (i.e. AOPs – adverse outcome pathways), and that incorporate exposure science will support a move away from traditional tests in animals and potentially provide more relevant safety assessments.  

The workshop aims to raise awareness of currently available NAMs and explore how regulatory application and acceptance of these tools can be accelerated by overcoming the most significant barriers to their implementation. 

Key objectives are to:

  • Showcase how NAMs are currently being used to enable and improve decision-making for chemical safety assessment.
  • Determine the barriers and scientific gaps that if addressed could accelerate the development and application of NAMs for regulatory assessments.
  • Explore new ways to speed up the validation and standardisation process of NAMs.
  • Identify short, medium and long-term objectives to ensure a smooth transition from traditional toxicology to integrated testing approaches.

The meeting is relevant for academic, regulatory and industry scientists with an interest in the development and application of NAMs. 

Register now via Zoom

NC3Rs event policy

The draft agenda for the workshop is below:

Day 1

Time Agenda Item
13.00 -13.05

Welcome and introductions

Professor John Colbourne, University of Birmingham (Chair)

Session 1

A vision for NAMs in safety testing

13.05 -13.30

A vision for regulatory application of NAMs – personal reflections

Professor Alan Boobis, Imperial College London

13.30 -13.55

New opportunities for NAM development and what can be achieved by Precision Toxicology

Professor John Colbourne, University of Birmingham

13.55 –14.05

Panel discussion

Session 2

OECD test method developments – current status of NAMs and lessons learnt

14.05 –14.30

Overview of recently adopted NAM OECD guidelines and future workplan

Dr Anne Gourmelon, OECD

14.30 –14.55

Validation and standardisation of latest NAMs

Dr Nicole Kleinstreuer, NICEATM

14.55 –15.10

Panel discussion

15.10 –15.25

Coffee break

Session 3

Recent research developments in NAMs – Part I

What is possible; what are the limitations; what are the hurdles; what are the potential applications and case-studies

15.25 –15.50

Increasing confidence in chemical grouping using omics-derived molecular data

Professor Mark Viant, Michabo Health Science Ltd

15.50 –16.15

Integrating in vitro bioactivity data, computational modelling and exposure science in animal-free cosmetic safety assessments

Dr Maria Baltazar, Unilever

16.15 –16.40

Using (Q)SAR models as part of a weight of evidence, to reduce reliance on animal testing and support regulatory assessments

Dr Adrian Fowkes, Lhasa Ltd

16.40 –16.55

Panel discussion

16.55 –17.00

Re-cap and close of day 1


Day 2

Time             Agenda Item

13.00 -13.05

Welcome to Day 2

Alan Boobis, Imperial College London (Chair)

Session 4

Recent research developments in NAMs – Part II

What is possible; what are the limitations; what are the hurdles; what are the potential applications and case-studies

13.05 –13.30

Microphysiological systems – what is possible and what are the limitations?

Dr Jason Ekert, GSK

13.30 –13.55

Importance of AOPs in NGRA – the case study of cardiotoxicity

Dr Luigi Margiotta-Casaluci, Kings College London

13.55 –14.20

Novel in vivo mechanistic toxicology approaches to inform regulatory testing

Dr Francisco Inesta-Vaquera, University of Dundee

14.20 –14.30

Panel discussion

14.30 –14.40

Coffee break

Session 5

NAMs and regulatory needs

What regulators need and how NAMs can be applied in a regulatory context – what are the opportunities and how to overcome the challenges/barriers?

14.40 –14.55

Barriers to and opportunities for the increased use of NAMs in the regulation of agrochemicals and biocides

Dr Susy Brescia, HSE CRD

14.55 –15.10

Non-animal methods and new approach methodologies in UK REACH registration

Dr Helen McGarry, HSE CRD

15.10 –15.25

The use of NAMs in regulatory assessments of cosmetics safety

Professor Qasim Chaudhry, University of Chester

15.25 –15.40

Current and future role of NAMs in regulatory assessments of food

Dr David Gott, FSA

15.40 –15.55

Acceptance of NAMs in the regulation of pharmaceuticals – what are the challenges and how they can be overcome

Dr David Jones, Independent

15.55 –16.10

Panel discussion

Session 6


Specific questions to be addressed by all speakers and selected panellists

16.10 –16.45

Questions and interactive discussion

16.45 –17.00

Re-cap, take-home messages and outlook