Online webinar “Good practices and resources to improve the utility of research data in regulatory assessments”

The webinar provided an overview of the state of play and the evidence base feeding into the development of the guidance.

The first part consisted of four presentations, covering an introduction to the policy challenge and to the OECD project (Antonio Franco) and examples of recent and ongoing research activities aimed at improving tools and approaches for the identification and regulatory consideration of research data (Anna Beronius, Philippe Rocca Serra, Iseult Lynch):
 

• The challenge of using (non-standard) research data in regulatory assessments and the OECD initiative (Antonio Franco, JRC, OECD WPHA Expert Group on research data)
• Experience and contributions from the SciRAP initiative (Anna Beronius, Karolinska Institutet, OECD WPHA Expert Group on research data)
• Enabling innovation: from data science research to regulatory application (Philippe Rocca-Serra, University of Oxford, Molecular data production and management of PrecisionTox)
• PARC perspective (Iseult Lynch, University of Birmingham, co-lead of PARC WP7 on FAIR data)

The presentations session was followed by an open discussion. The audience engaged on some of the crucial elements of the challenge, including:

• The long-term sustainability and accessibility of research databases and their interoperability with governmental databases.
• The utility to interconnect established research initiatives to governmental databases (e.g. future Common Data Platform on Chemicals to be hosted by ECHA or echem Portal) to ensure long term sustainability and workability. There is however no one size fits-all-solution for data findability and accessibility.
• The importance to provide access to the detailed procedure used to generate the data as well as to the raw data.
• The need to provide guidance by introducing and promoting good practice, available tools and approaches while not to being prescriptive about the use of specific tools. This reflects the fact different tools may be preferable, depending on the jurisdiction and context, while sharing common basic principles.
• The challenge to address evaluation of “relevance”, which is context dependent and changes over time. In this context, the utility of meta-data (e.g. AOP ontology) to support and harmonise relevance evaluations was highlighted.
• The importance to find ways that the two communities (researchers and safety assessors) to better communicate between them. Researchers are not aware of what is needed for their research to be used in regulatory assessments.
• The utility to publish datasets as final outcomes of scientific projects. Papers presenting the final dataset at the end of a project are very useful and also well cited.

Contact JRC-F3-MEETINGSec [dot] europa [dot] eu (JRC-F3-MEETINGS[at]ec[dot]europa[dot]eu) to get access to the recording.