In June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur. within approximately 5 years.
There are a number of Ph. Eur. texts – covering a variety of topics, including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected by this decision. However, the Ph. Eur. Commission is committed, for all these texts, to replacing the test for pyrogens with a suitable in vitro alternative, ultimately leading to the complete elimination of the RPT.
This three-day event, co-organised with the European Partnership for Alternative Approaches to Animal Testing (EPAA), will focus on the future of pyrogenicity testing.
Topics on the agenda include an in-depth presentation of the Ph. Eur.’s strategy for phasing out the RPT, the use of the monocyte activation test (MAT), the viewpoints of regulators and industry representatives, as well as perspectives from outside Europe on animal-free pyrogenicity testing. The event will also include a training session on the MAT, which will give participants the opportunity to share information on hands-on skills and troubleshooting solutions and provide opportunities for dialogue with the specialists.
SAVE THE DATE: This event will take place from 14 to 16 February 2023, in Brussels, Belgium.
More information on the programme and how to register for this event will be published soon.
You may also be interested to read more about:
- EDQM: Alternatives to Animal Testing
- European Partnership for Alternative Approaches to Animal Testing (EPAA)