Science & Dialogue : Panel Discussion Series

Presentation

In order to contribute to greater acceptance of NAMs (reliability, robustness and method validation), the Pro Anima Scientific Committee, supported by PARC and the FC3R, is organizing and leading a series of discussions with key players (researchers, industry, regulators).

In light of the challenges notably identified by PARC as part of its roadmap for NGRA (Next Generation Risk Assessment), the discussions revolve around the following themes : toxicology, NAMs and regulation.

Panel discussions are free of charge, and registration is required. A registration form is available one month before each session, with the opportunity to submit questions to panelists in advance.

Objectives

• Contribute to a greater acceptance of New Approach Methodologies and Non-Animal Methods (NAMs) for toxicology testing and regulation
• Foster cross-disciplinary dialogue between research, industry and regulatory operators
• Identify current and future scientific and regulatory obstacles and solutions
• Create content to raise awareness and educate the general public about these advances

Panel Discussions Coming Up

Session 2 : Harmonization of NAMs — Can it really be global ? 

Save the date : Thursday June 27, 1 – 2:15pm CET

Registration openning soon, stay tunned !

Previous Panel Discussions

Session 1 : Regulatory acceptance of NAMs — How to define criteria ?

Thursday April 25, 1 – 2pm CET

It is getting clearer now that if we want to accelerate the adoption of NAMs (non-animal new approach methodologies), there is a need for more global harmonization of the criteria used for qualification of the techniques and validation of those criteria. To ensure confidence in new models, regulatory agencies need these to be qualified, confirming they are robust, that they faithfully mimic human level functionalities and that it is appropriate for specific contexts of use (COU). This panel discussion tackled this challenging objective of defining acceptance criteria.

On this occasion, we had the pleasure to welcome :

Watch the replay

Available soon !

PANELLISTS

Dr Carl Westmoreland

Carl has worked at Unilever for over 20 years and is director of Science & Technologies at the Safety and Environmental Assurance Centre (SEAC) in the UK. A large part of his role focuses on the strategic development and application of the science needed for non-animal, risk-based safety assessments. Previously, he received his PhD from the University of Surrey, UK and worked for 10 years at GlaxoSmithKline. Carl represents Unilever on several external groups including EPAA, ECETOC, UK NC3Rs and Cefic and has previously served on many scientific groups including the EURL-ECVAM Scientific Advisory Committee. Carl is also a Fellow on the British Toxicology Society and a member of the UK Animals in Science Committee.

Prof Ellen Fritsche

Ellen is the idea generator and scientific managing director of the DNTOX GmbH. She is also the director of the SCAHT — Swiss Centre for Applied Human Toxicology. Since 2002, her research focus has been on the establishment and scientific/mechanistic validation of human focused methods (or NAMs) with the aim of regulatory application. Her neurosphere methods for developmental neurotoxicity (DNT) testing are an integral part of the DNT in vitro battery (IVB) promoted for regulatory application by the OECD, EFSA and the US EPA.

Dr Clive Roper

For more than 25 years, Clive has been an active toxicologist, having developed models resulting in direct replacement of animals. He founded his consulting business, Roper Toxicology Consulting Limited in 2021, dedicated to the use, application, and acceptance of NAMs. In April 2023, he was appointed Vice President of ESTIV. He is a Fellow of the Royal Society of Biology, European Registered Toxicologist, member of the Roundtable of Toxicology Consultants, Society of Toxicology and American College of Toxicology. Clive is on the board of directors of institutions such as the UK NC3Rs, the US 3Rs Collaborative, and PeptiMatrix (manufacturing animal free media components).

MODERATOR

Prof Robert Lee

Robert is Professor of Law of Birmingham Law School. He is a former Head of School and Director of the Centre for Employability, Professional Legal Education and Research (CEPLER). He has acted as specialist adviser to the European Parliament, the European Commission, the House of Commons and the National Assembly for Wales and has worked for the Department for the Environment in Northern Ireland (drafting environmental legislation) and the UN Development Programme, among other things. He has undertaken research projects on the regulation of technologies for several UK agencies. He is an honorary life member of the UK Environmental Association and a Fellow of the Academy of Social Sciences. He is actively engaged with research projects relating to technology regulation including the Horizon 2020 PrecisionTox programme for which he co authored a report on the barriers to the uptake of NAMs.

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