Theme I Safety and Efficacy Testing of Chemicals, Pharmaceuticals and Biologicals Session I-1: Potency and safety testing of human vaccines Session I-1: Oral presentations

the eDQM (european Directorate for the Quality of Medicines & Health Care, Council of europe) is a standard setting body involved in ensuring the quality of medicines, including vaccines for human and veterinary use. this is done through the elaboration and publication of the european Pharmacopoeia (Ph. eur.). In addition, the eDQM runs the Biological Standardisation Programme (BSP) which elaborates reference standards and validates methods, including three Rs approaches for the quality control of biologicals. Furthermore the eDQM is the secretariat of the european network of public control laboratories that are involved in the official control authority batch release of human and veterinary vaccines. It is through this process that the public control laboratories use animals for the quality control of vaccines. the three Rs activities of eDQM are based on the “european Convention for the protection of vertebrate animals used for experimental and other scientific purposes”, which was published by the Council of Europe in 1986 and which represents the first international legal text in this field. A highlight of eDQM activities in the application of three Rs principles will be presented including insight on challenges for development and implementation of alternative methods. examples will include projects with successful introduction of alternative assays for the assessment of the potency of human and veterinary vaccines. An overview of future plans in this field will also be presented. I-1-107 EDQM’s Three Rs activities in the field of quality control of vaccines