4.1 Article

Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report

Journal

BIOLOGICALS
Volume 78, Issue -, Pages 17-26

Publisher

ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.biologicals.2022.06.003

Keywords

Vaccines; Batch release testing; Batch safety test; Abnormal toxicity test; Public health

Funding

  1. EFPIA
  2. HSI
  3. Bill & Melinda Gates Foundation

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The workshop aimed to accelerate the deletion of the Abnormal Toxicity Test for vaccines and biologicals and saw participation from over a hundred representatives from international organizations, pharmaceutical industries, and regulatory authorities of 28 countries. Participants shared country-specific regulatory requirements and discussed specific actions to further secure the deletion of ATT globally.
This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and bi-ologicals. Planning common next steps was organized on October 14th, 2021, by the Animal Free Safety Assessment Collaboration (AFSA), the Humane Society International (HSI), the European Federation of Phar-maceutical Industries and Associations (EFPIA), in collaboration with the International Alliance of Biological Standardization (IABS). The workshop saw a participation of over a hundred representatives from international organizations, pharmaceutical industries and associations, and regulatory authorities of 28 countries. Partici-pants reported on country-and region-specific regulatory requirements and, where present, on the perspectives on the waiving and elimination of the Abnormal Toxicity Test. With AFSA, HSI, EFPIA and IABS representatives as facilitators, the participants also discussed specific country/global actions to further secure the deletion of ATT from all regulatory requirements worldwide.

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