Abstract：
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.
摘要：
监管机构要求进行兽医批量释放测试，以确认疫苗的效力和安全性，但是这些测试传统上依赖于大量的实验动物。疫苗研究和开发的进展为替代体内测试提供了越来越多的机会，一些利益相关者在将3Rs元素纳入质量控制策略方面取得了重大进展。由无动物安全评估合作组织联合组织了一个由三部分组成的系列活动，题为“兽医疫苗批量释放测试中的3Rs实施：当前的最新技术和未来的机会”，HealthforAnimals,和国际生物标准化联盟。两个网络研讨会和一个研讨会旨在概述兽医批量释放测试的最先进的非动物方法。这些活动包括关于删除过时安全测试的状态的信息，以及欧洲目前实施的举措，北美,和亚太利益攸关方对3R的实施和监管接受。这些事件有助于更好地理解3R实施的障碍。与会者强调需要公开交流，利益相关者之间的持续合作，和监管要求的国际协调，以帮助加速接受。尽管面临挑战,参加这次由三部分组成的活动的国家都承诺推动接受替代方法。
