Abstract:
Transition to in vitro alternative methods from in vivo in vaccine release testing and characterization, the implementation of the consistency approach, and a drive towards international harmonization of regulatory requirements are most pressing needs in the field of vaccines. It is critical for global vaccine community to work together to secure effective progress towards animal welfare and to ensure that vaccines of ever higher quality can reach the populations in need in the shortest possible timeframe. Advancements in the field, case studies, and experiences from Low and Middle Income Countries (LMIC) were the topics discussed by an international gathering of experts during a recent conference titled \"Animal Testing for Vaccines - Implementing Replacement, Reduction and Refinement: Challenges and Priorities\". This conference was organized by the International Alliance for Biological Standardization (IABS), and held in Bangkok, Thailand on December 3 and 4 2019. Participants comprised stakeholders from many parts of the world, including vaccine developers, manufacturers and regulators from Asia, Europe, North America, Australia and New Zealand. In interactive workshops and vibrant panel discussions, the attendees worked together to identify the remaining barriers to validation, acceptance and implementation of alternative methods, and how harmonization could be promoted, especially for LMICs.
摘要:
从体内疫苗释放测试和表征过渡到体外替代方法,一致性方法的实施,和推动国际协调监管要求是疫苗领域最紧迫的需求。全球疫苗界必须共同努力,确保在动物福利方面取得有效进展,并确保更高质量的疫苗能够在尽可能短的时间内送达有需要的人群。领域的进步,案例研究,来自低收入和中等收入国家(LMIC)的经验是最近一次题为“疫苗的动物试验——实施替代,减少和改进:挑战和优先事项“。本次会议由国际生物标准化联盟(IABS)组织,并在曼谷举行,泰国于2019年12月3日和4日。与会者包括来自世界许多地方的利益相关者,包括疫苗开发商,来自亚洲的制造商和监管机构,欧洲,北美,澳大利亚和新西兰。在互动研讨会和充满活力的小组讨论中,与会者共同努力,确定剩余的验证障碍,接受和实施替代方法,以及如何促进协调,特别是对于LMICs。