The report of the common IABS - EMAV meeting about Autogenous vaccines, held on 14-16 September in Munich, is available at the scientific journal BIOLOGICALS (Volume 76, April 2022, Pages 36-41)
BIOLOGICALS, the journal of the International Alliance for Biological Standardization (ISSN: 1045-1056) provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine.
The open access version of the scientific note “Autogenous vaccines: Quality of production and movement in a common market” by Kornelia Grein, Carmen Jungbaeck and Vaughn Kubiak, published in BIOLOGICALS, is accessible at Elsevier and ScienceDirect at BIOLOGICALS publication
The congress report in BIOLOGICALS summarised that “the international meeting, held on the Ludwig-Maximilians-University in Munich, Germany, on 14–16 September 2021, explored the expectations and views of different stakeholders regarding the implementation of the new veterinary medicines Regulation (Reg. (EU) 2019/6) in respect to inactivated Autogenous vaccines in non-notifiable diseases.
Guidance documents on specific Good Manufacturing Practice (GMP) for Autogenous vaccines are scheduled to be developed at EU and a wider international level in the future. Presentations and discussions by the experts from regulatory authorities, industry and users made it apparent that their views on the quality requirements for the starting materials as well as quality standards for premises, personnel and manufacturing were broadly aligned for most of the aspects considered. The conclusions and recommendations of this meeting are expected to facilitate the development of urgently needed guidance documents for a harmonised implementation of this element of the Regulation.”
For more information see EMAV Proposal: “EU-GMP-Annex for Autogenous vaccines”, available at: EMAV Proposal.
Additional information about the content of the Munich congress are published at the Congress website