Note: Only for participants also registered to the ESTIV 2026 Congress.
The successful uptake of New Approach Methodologies (NAMs) in research, regulatory decision-making, and standardisation depends not only on scientific excellence, but also on how data and other research outputs are generated, documented, managed, and shared. Poorly structured or insufficiently described data remain a major barrier to reproducibility, validation, regulatory acceptance, and long-term reuse.
This pre-congress workshop will provide a practical and accessible introduction to research output management tailored specifically to NAMs, with a strong focus on Data Management Plans (DMPs), the FAIR principles (Findable, Accessible, Interoperable, Reusable), and emerging expectations from funders, regulators, and international organisations. Participants will learn why DMPs are more than a formal requirement, how they can be used as a strategic tool throughout the lifecycle of a NAM, and how FAIR-aligned data practices support:
- method validation and transfer,
- cross-laboratory comparability,
- integration into Defined Approaches and IATA,
- regulatory review and long-term impact.
The workshop will also address research outputs beyond raw data, including protocols, metadata, models, ontologies, reports, and digital tools, and will discuss how these outputs can be structured to maximise visibility, credibility, and reuse in line with Open Science and regulatory needs. Through concrete examples drawn from EU-funded projects and real-world NAM applications, the workshop will highlight common pitfalls, practical solutions, and realistic workflows that can be implemented without excessive administrative burden.
Draft programme
- 9:00-9:15 opening – Danyel Jennen ( Maastricht University, the Netherlands & ONTOX)
- 9:15-10:00 Data management for in vitro toxicology – Luiz Ladeira (University of Liège & ESTIV & ONTOX)
- 10:00-11:00 Hands-on session – Data Stewardship Wizard (DSW): Creating data management plans– Danyel Jennen (Maastricht University, the Netherlands & ONTOX)
- 11:00-11:15 Coffee break
- 11:15-12:00 OECD perspectives on research data integrity in regulatory context – Anne Gourmelon (OECD, France) – t.b.c.
- 12:00-13:00 Hands-on session – ToxTempAssistent: Filling in ToxTemps using LLMs – Jente Houweling (RIVM National Institute for Public Health and Environment, Netherlands)
Who should attend
- Researchers developing or applying NAMs
- Early-career scientists and PhD students
- Project and work-package leaders
- Coordinators of EU-funded projects (e.g. Horizon Europe)
- Industry scientists and regulatory stakeholders involved in NAM implementation
Co-organised under the ONTOX-ESTIV Memorandum of Understanding