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

This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. 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...

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Bibliographic Details
Published in:Biologicals 2022-07, Vol.78, p.17-26
Main Authors: Viviani, Laura, Reid, Kirsty, Gastineau, Thierry, Milne, Catherine, Smith, Dean, Levis, Robin, Lei, Dianliang, van Ooij, Mark, Gilbert, Philippe Alexandre, Vandeputte, Joris, Xie, Jianxun, Madhuri, Leena, Shaid, Shahjahan, Kubiak, Vaughn, Suri, Rajinder, Mizukami, Takuo, Shirasaki, Yoshihisa, Li, Xiantang, Zhou, Ying-Ying, Trapkova, Alla, Goel, Sunil, Prakash, Jai, Subagio, Amrullah Aninditio, Suwarni, Eniek, Jung, Kyung Jin, Sanyal, Gautam, Das, Pradip, Coppens, Emmanuelle, Wright, David, Peng, Zhechu, Northeved, Helle, Jungbäck, Carmen, Kirpitchenok, Tatiana, Del Pace, Lorenzo, Seo, Borami, Poojary, Brinda, Ottoni, Antoniana
Format: Article
Language:English
Subjects:
Drug Industry
Humans
Meeting Report
Reference Standards
Toxicity Tests
Vaccines - adverse effects
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Summary:This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. 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 Pharmaceutical 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. Participants 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.
ISSN:1045-1056
1095-8320
1095-8320
DOI:10.1016/j.biologicals.2022.06.003