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

Autor: Laura Viviani, Kirsty Reid, Thierry Gastineau, Catherine Milne, Dean Smith, Robin Levis, Dianliang Lei, Mark van Ooij, Philippe Alexandre Gilbert, Joris Vandeputte, Jianxun Xie, Leena Madhuri, Shahjahan Shaid, Vaughn Kubiak, Rajinder Suri, Takuo Mizukami, Yoshihisa Shirasaki, Xiantang Li, Ying-Ying Zhou, Alla Trapkova, Sunil Goel, Jai Prakash, Amrullah Aninditio Subagio, Eniek Suwarni, Kyung Jin Jung, Gautam Sanyal, Pradip Das, Emmanuelle Coppens, David Wright, Zhechu Peng, Helle Northeved, Carmen Jungbäck, Tatiana Kirpitchenok, Lorenzo Del Pace, Borami Seo, Brinda Poojary, Antoniana Ottoni
Rok vydání: 2022
Předmět:
Zdroj: Biologicals : journal of the International Association of Biological Standardization. 78
ISSN: 1095-8320
Popis: 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.
Databáze: OpenAIRE
Externí odkaz: