In February 2023, the EDQM and European Partnership for Alternative Approaches to Animal Testing (EPAA) hosted a landmark conference to present the European Pharmacopoeia (Ph. Eur.) Commission’s strategy to phase out the rabbit pyrogen test (RPT) and transition to modern, animal-free alternatives. This shift is guided by ethical imperatives in line with the principles of Directive 2010/63/EU on the protection of animals used for scientific purposes and grounded in state-of-the-art scientific innovation, with a strong focus on enhancing patient safety.

Since then, all references to the RPT have been deleted from Ph. Eur. texts, with an implementation date of 1 July 2025, and the dedicated RPT chapter will be officially suppressed as of 1 January 2026. Rather than prescribing a single replacement test, the Ph. Eur. has introduced a new general chapter, 5.1.13. Pyrogenicity, which places the onus on users to select the most appropriate pyrogenicity testing strategy based on scientific justification and a risk assessment.

Among the available alternatives, the monocyte activation test (MAT) is rapidly gaining ground as a scientifically robust, animal-free method.

This follow-up symposium will:

• provide updates on the implementation of the RPT phase-out strategy across Europe;
• explore the challenges and solutions encountered during the transition to MAT;
• explore the status of recombinant reagents for use in the bacterial endotoxins test (BET);
• share insights into how other pharmacopoeias and regulatory frameworks outside Europe have adapted in response to the Ph. Eur.’s initiative;
• bring forward perspectives from regulators, industry, and international stakeholders on the future of animal-free pyrogenicity testing.

The symposium will also offer an opportunity for participants to familiarise themselves with the current use of recombinant reagents, such as recombinant Factor C and recombinant Cascade Reagents for use in the bacterial endotoxins test (BET).

• Take a closer look at the programme

This symposium will be of particular interest to professionals from the pharmaceutical and biopharmaceutical industries, contract laboratories and health authorities.

Participation is free of charge.

This symposium will take place in hybrid format - attendees can participate in-person at the CCAB in Brussels or online via a videoconferencing service. 

REGISTER NOW

After registration, you will receive an automatic email. Onsite registration confirmation will be sent later.

Important: Registrants are advised to refrain from making any travel arrangements until they have received this confirmation.