Creation of a technical platform for human and veterinary vaccines dealing with general strategies and policies to introduce the Consistency Approach in routine release activities, prioritising the replacement of compendial in vivo tests with validated alternative in vitro tests, defining minimal acceptance criteria for alternative in vitro tests, reviewing work plans and reports provided by human and veterinary vaccine task forces or groups working on test development and validation with the ultimate goal of synchronizing initiatives for 3Rs methods in safety and potency testing of vaccines in Europe.
The project is in three phases:
Development of alternative approaches for Quality Control of vaccines necessitates early co-ordinated dialogue and collaboration between industry and other relevant stakeholders, Control Authorities and Regulatory Authorities. EPAA makes this possible by constituting a unique platform where all parties can apply their technical experience to the search and the development of alternatives to current in vivo testing. It is a genuine partnership where the Commission provides visibility, and all parties committed to alternatives provide technical know-how; EPAA can provide a new perspective on and a new impetus for the development and implementation of alternative approaches for vaccine quality and safety assessment. The technical platform project does not aim to duplicate existing structures like ECVAM and EDQM activities but to enable early collaboration in the development of alternatives.
Potential benefits of the vaccines consistency approach are very significant in terms of animal welfare (up to 15 million of animals saved a year) and refinement and in terms of better science and faster results.
European Commission, National regulators, European Vaccines producers, observers from US, Canada and India
January 2014 (TBD) Joint Veterinary & Human Rabies Vaccines Workshop
Q2 2015 Vaccines Consistency Approach Conference