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At a meeting of the EMAV members in Bologna, the participants summarized some of the association's core activities, such as close and ongoing consultations with key stakeholders, particularly with the European Commission, regarding continuously changing processes and timelines for the implementation of Regulation (EU) 2019/6 for autogenous vaccines and for the publication of the implementing act/GMP for autogenous vaccines. But the participants also discussed work ...

This year, the members of the association met in Bologna, Italy, for their annual general assembly. At this meeting, Klaus-Peter Behr, Chairman of EMAV, pointed out that during the reporting period, EMAV was confronted with a number of new challenges regarding the manufacturing and future availability of autogenous vaccines, which EMAV was able to successfully overcome thanks to consistently focused work, a proven and dedicated team and the use of an established network.

In recent months core activities of EMAV included the close consultation of EMAV in particular with the European Commission in the changed process and timeline for the implementation of the Reg. (EU) 2019/6 and for the publication of a GMP standard for autogenous vaccines, the work on new EMAV projects, like for rationales for the EMAV GMP proposal, for a new EMAV ROADMAP and for epidemiological issues and the admission of new EMAV members, Dr. Klaus-Peter Behr, Chairman of the association, reported at the annual meeting in May in Berlin.

At the association's annual meeting, Klaus-Peter Behr, Chairman of EMAV, welcomed two new EMAV members, Syva from Spain and FILAVIE from France.

At an EMAV-Workshop session end of April in Barcelona experts for the manufacturing and use of autogenous vaccines (AV) from all over Europe discussed aspects and expected consequences in the implementation of Reg. (EU) 2019/6 for AV thoroughly – based on the presentations “Expected next steps and timelines for the development of a GMP guideline for AV by EMA/GMDP IWG” by António Azevedo (Senior Scientific Specialist GMP, Quality and Safety of Medicines Department, European Medicines Agency).