3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report - Anses - Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail Accéder directement au contenu
Article Dans Une Revue Biologicals Année : 2023

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report

Laura Viviani
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Rick Clayton
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Liys Desmayanti
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David John
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Carmen Jungbaëck
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M. Kalaivani
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Imke Kross
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Catherine Lang
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Ni Made Ria Isriyanthi
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Michelle Rubbrecht
Botond Siklódi
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Brajesh Singh
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Geetha Srinivas
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Paul Stickings
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Catrina Stirling
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Pushpanathan Sundram
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Mária Szabó
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Anne Thomas
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Mariette van den Berg
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Angela Walker
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Corinne Philippe
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Joris Vandeputte
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Résumé

Regulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled “3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-art and future opportunities” was jointly organized by the Animal-Free Safety Assessment Collaboration, HealthforAnimals, and the International Alliance of Biological Standardization. Two webinars and a workshop aimed to outline the state-of-the-art non-animal approaches for veterinary batch-release testing. The events included information on the state of the deletion of obsolete safety testing and the current initiatives implemented by European, North American, and Asian-Pacific stakeholders on 3Rs implementation and regulatory acceptance. The events contributed to a better understanding of the barriers to 3Rs implementation. Participants highlighted the need for open communication, continued collaboration between stakeholders, and international harmonization of regulatory requirements to help accelerate acceptance. Despite the challenges, the countries represented at this three-part event have shared their commitments to advancing the acceptance of alternative methods.
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anses-04228077 , version 1 (04-10-2023)

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Laura Viviani, Elisabeth Balks, Sonja Beken, Anna-Maria Brady, Rick Clayton, et al.. 3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report. Biologicals, 2023, 83, pp.101695. ⟨10.1016/j.biologicals.2023.101695⟩. ⟨anses-04228077⟩

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