This workshop aims to facilitate the implementation of the new in vitro cell-based assays for in-process quality control, validated through collaborative study BSP130 – a joint EDQM-EPAA project successfully completed in 2018. The workshop will provide a forum to discuss study results and share practical experience and knowledge of these new methods with BSP130 study participants, control laboratories, regulators and other relevant stakeholders.
This workshop will be of particular interest to those working in vaccine manufacture and/or involved in the control and licencing of vaccines for veterinary use. The workshop programme is available below. Further information on how to register will be available soon.
- More on 'alternatives to animal testing'
- More information on the BSP Programme
- More on the upcoming EDQM training session on the 'Management of extraneous agents in immunological veterinary medicinal products'
Background
EPAA
The EPAA is a public-private partnership across seven industry sectors and between European Commission and industry stakeholders. Launched in 2005, it comprises 37 companies, 8 European trade federations and 5 Directorates-General of the European Commission.
EURL ECVAM
EURL ECVAM is an integral part of the Joint Research Centre (JRC, Ispra, Italy), the science and knowledge service of the European Commission. Its mandate, as specified in Directive 2010/63/EU, is linked to the advancement of the “Replacement, Reduction and Refinement” (the 3Rs) of animal procedures. Current activities cover research and collaboration with research initiatives, validation studies, dissemination of information, knowledge sharing, promotion of alternative methods in an international context across disciplines and sectors.
EDQM, Council of Europe
The EDQM is a leading organisation that protects public health by enabling the development, supporting the implementation, and the monitoring the application of quality standards for safe medicines and their safe use. The standards are recognised as a scientific benchmark worldwide. The European Pharmacopoeia is legally binding in member states. Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.