Topical Scientific Workshop - New Approach Methodologies in Regulatory Science
19-20 April 2016 | Helsinki, Finland
Topical scientific workshops of the European Chemicals Agency (ECHA) aim to foster discussion among academia, regulators, industry and other stakeholders on the possible regulatory impacts of the latest scientific developments. An anticipated outcome of these workshops is the emergence of new or improved approaches which may be applied to the implementation of the REACH, CLP and biocides regulations.
Aim of the workshop
The Topical Scientific Workshop on New Approach Methodologies in Regulatory Science will explore the potential regulatory benefits arising from fundamental change in scientific thinking. Complex toxicological apical endpoints cannot be predicted by a single non-standard test. Instead, it is necessary to combine multiple lines of evidence (including ‘-omics' and high-throughput screening methods) to predict the hazardous property with tools to facilitate this integration of evidence.
Two motivating drivers for the workshop are:
- A better understanding of the underlying biology behind how chemicals cause adverse effects to human health; and
- New tools and techniques that provide a huge amount of data to be used in solving regulatory issues.
The workshop draws inspiration from the EU research programme SEURAT-1 and the US Tox21 initiative, but also takes into account general progress from the scientific field.
Format and themes
The discussions will be held in plenary sessions and break-out groups and will be complemented by a poster exhibition. In addition to the keynote presentations, a selection of case studies will be presented in the plenary sessions and discussed in-depth in the break-out groups.
The central theme is rational combination of data from new-approach methods on an individual substance to make an overall fit-for-purpose prediction for it. The idea is to discuss issues framed from the regulatory perspective with scientists who are experts in the field. Combining the expertise of scientists, regulators and industry professionals should help to address the biggest challenges and work out practical solutions.
- Theme 1: Definitive hazard assessment, particularly read-across
This theme covers the short-term achievable aim of using new-approach evidence to improve the quality of read-across and chemical categories by presenting case studies that demonstrate the usefulness of different types of new approach methodologies data in read-across and an added value of such approach compared to the situation where read-across hypothesis is not supported by that data.
The plenary presentations will serve as a basis for the break-out group discussions in the afternoon of the first day.
Other objectives of this first day are to gain experience on how new approach methodologies can be used by registrants; take a reality check of how read-across works on high quality risk assessment cases supported by mechanistic evidence; and especially to identify further development needs.
- Theme 2: Screening and priority setting
- Theme 3: Prospects for regulatory science
These themes will cover other means of assessing individual substances and using new-approach methods for screening/priority setting. This can lead to discussions about how to make the most effective use of this new kind of evidence when not restricted to the current regulatory approach (i.e. ‘new paradigm' considerations).
Examples of theme-related cases will be presented by the regulatory agencies from the USA, Canada and Australia. These examples are followed by presentations on other aspects of application of new approach methodologies data in regulatory science. The focus of the afternoon will be on regulatory needs for experimental assays design, reporting of new approach methodology generated data for regulatory use as well as on the availability and use of existing frameworks on weight of evidence, mode of action, adverse outcome pathway for incorporation of new approach methodologies data into regulatory hazard assessment.
We hope to better understand how to move forward in solving regulatory challenges. We may do this by formulating ideas for better approaches that can already be adopted as the science is ‘ripe'. We may help improve the understanding when the science may not be immediately ready to contribute to solving regulatory issues. Equally important, the discussions will help steer scientific R&D by communicating important regulatory challenges in both the short and the long term.
Discussions could bring ideas, for example, for the applicability and challenges related to new approach methodologies in the context of definite hazard assessment and of prioritisation and screening as well as identifying which aspects of new approach methodologies need to be further developed to increase regulatory applications.
Scientific and local organising committee members
Scientific committee members
The international Scientific Committee is chaired by Dr Tomasz Sobanski from ECHA. The committee members are:
Dr Tara Barton-Maclaren, Health Canada, Canada
Dr Sonja Beken, European Medicines Agency, United Kingdom
Dr Elisabet Berggren, Joint Research Centre, European Commission, Italy
Professor Ian Cotgreave, Swetox, Sweden
Professor Mark Cronin, Liverpool John Moores University, United Kingdom
Dr Karel De Raat, ECHA, Finland
Dr Jean-Lou Dorne, European Food Safety Authority, Italy
Dr Matthias Herzler, Federal Institute for Risk Assessment, Germany
Dr Derek Knight, ECHA, Finland
Dr Catherine Mahony, Procter & Gamble, United Kingdom
Dr Tatiana Netzeva, ECHA, Finland
Dr Christine Norman, Health Canada, Canada
Dr Kerry Nugent, National Industrial Chemicals Notification and Assessment Scheme, Australia
Dr Magda Sachana, Organisation for Economic Cooperation and Development, France
Professor Terry Schultz, University of Tennessee, Knoxville, USA
Professor Michael Schwarz, Tübingen University, Germany
Dr Rusty Thomas, US Environmental Protection Agency, USA
Dr Bennard van Ravenzwaay, BASF, Germany
Local organising committee members, ECHA
Dr Anja Klauk
Dr Derek Knight
Dr Tomasz Sobanski
Dr Kaihsu Tai (chair)
Based on the expressions of interest, official invitations to the workshop will be sent in early December 2015. Participation in the workshop is possible by invitation only.
For specific questions, contact: scientificevents (at) echa.europa.eu