Contract research organisation days - bridging in vivo laboratories and regulatory scientists

Contract research organisation days take place at ECHA premises in Helsinki on 19-20 November 2024.

ECHA is committed to reducing vertebrate animal testing, preventing duplicate testing and refining the methods currently used. To this end, ECHA wants to establish an open discussion between contract research organisations (CROs) performing animal studies and ECHA’s regulatory scientists assessing those studies.

In assessing industrial chemicals that are potentially hazardous to human health, animal studies cannot yet be fully avoided. Therefore, the aim in conducting such studies is to ensure that the results are of highest possible quality, reliable and useful. CROs are important stakeholders in generating data for identifying chemical hazards.

Scope and agenda

The aim of the event is to:

• share and discuss with CRO representatives the learnings in hazard assessment, where ECHA’s scientists have identified reoccurring issues that may prevent the regulatory acceptance of studies.
• receive feedback from CROs to understand the most common challenges when performing frequently requested animal studies for REACH purposes (eg. OECD TGs 408, 414, 422, 443, 475, 489 studies).

The final agenda will be published later, but preliminary topics include:

• Dose-selection in in vivo toxicological studies (genotoxicity and reprotoxicity) to realistically identify hazardous properties of substances,
• Interpreting “severe suffering” especially in relation to top dose selection, and other ethics considerations faced by CROs,
• Interpreting study result in genotoxicity studies,
• GLP compliance,
• Problems in test material administration and route of administration,
• Approaches for test material characterisation (i.e. own analysis by the CRO vs. analytical certificates from the study sponsor),
• Optional cryopreservation of tissues in repeated dose toxicity studies to enable omics measurements.

Participants are also invited to suggest topics.

Who is the event for?

The event is an open face-to-face meeting for representatives of contract research organisations both in and outside the EU, conducting animal studies to meet the human health information requirements for REACH purposes and under the GLP Directive. The contract research organisation representatives are preferably the personnel in charge of the studies (e.g. study directors) or those conducting the studies. The event is free of charge, but we expect you to cover your own travel and accommodation expenses. Lunch and refreshments will be provided by ECHA.

Unfortunately, there is no possibility to join online, and the event will not be recorded.

Registration

Register here by 31 August 2024

As this is the first event of this kind, and to ensure ample participation of the interested organisations, we unfortunately have to limit participation to max. two persons per organisation. We may have to prioritise attendees if, based on the initial number of registrations, our capacity is exceeded.

Your attendance will be confirmed after the registration deadline has expired.

Consultation meeting on EOGRTS test guideline implementation 21 November 2024

Immediately after the CRO days, on Thursday 21 November 2024, ECHA will host a consultation meeting in collaboration with the OECD Working Group of National Co-ordinators of the Test Guidelines (WNT). This consultation meeting focuses on unexpected/challenging findings in the OECD test guideline on Extended One-Generation Reproductive Toxicity Study (EOGRTS, OECD TG 443). The OECD WNT consultation meeting is targeted at CROs conducting EOGRT studies. Organisations will be invited separately in due course.

Contact

If you have any questions, please contact us in evaluation_feedback(at)echa.europa.eu and indicate in the Subject field “CRO days 2024” for efficient processing of your question.