Biologicals ( IF 1.7 ) Pub Date : 2019-11-04 , DOI: 10.1016/j.biologicals.2019.10.007 Laura Viviani 1 , Marlies Halder 2 , Marion Gruber 3 , Lukas Bruckner 4 , Klaus Cussler 5 , Gautam Sanyal 6 , Geetha Srinivas 7 , Sunil Goel 8 , Marianne Kaashoek 9 , Derek Litthauer 10 , Arthur Leonardo Lopes da Silva 11 , Elena Sakanyan 12 , Patricia Aprea 13 , Hongtao Jin 14 , Joris Vandeputte 15 , Troy Seidle 1 , Dimitriy Yakunin 16
This one-day symposium organized by Humane Society International (HSI) brought together 18 international experts from Argentina, Brazil, China, Europe, India, Russia, South Africa and the United States to discuss the elimination of the abnormal toxicity test (ATT) from the testing requirements for human vaccines as well as the target animal batch safety test (TABST) and the laboratory animal batch safety test (LABST) for veterinary vaccines. Participants reported on country-specific regulatory requirements and, where present, the perspectives on waiver and elimination of those tests. In addition, the attendees, with HSI in the role of facilitator, moved to define the barriers to the complete elimination or waiving of these tests. This report expounds the outcomes of the symposium, and introduces a proposed roadmap – populated with country specific activities – for the elimination of these tests.