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Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states
Biologicals ( IF 1.7 ) Pub Date : 2023-10-03 , DOI: 10.1016/j.biologicals.2023.101712
Sun Bo Shim 1 , Chan Woong Choi 1 , Jin Ho Shin 2 , Jong Won Kim 3 , Silke Schepelmann 4 , Jae Ho Jung 5 , Harish Chander 6 , Ratih Pujilestari 7 , Madoka Kuramitsu 8 , Masaki Ochiai 8 , Nee Yuan Qi 9 , Geraldine N Dimapilis 10 , Luu Thi Dung 11 , Hyung Sil Moon 1 , In Soo Shin 1
Affiliation  

The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online. The theme of this meeting was ‘Quality Control Issues and International Trends for Biologicals including Vaccines and Plasma-Derived Medicinal Products.’ Three special speeches were presented on sharing the quality control system for biologicals, including NCLs' considerations in preparing the WHO Listed Authorities and sharing MFDS experiences. Furthermore, the participating NCLs shared country-specific issues related to national lot releases during the COVID-19 pandemic and acknowledged the meeting’s crucial role in response preparedness for pandemic emergencies and enhancing regulatory capacity through coalitions and information exchange among NCLs. The NIFDS will cooperate closely with other Asian NCLs to enhance biological product quality control, aiming to establish regional standards and standardize test methods through collaboration.



中文翻译:

世界卫生组织西太平洋和东南亚成员国疫苗和生物制品国家控制实验室第七次会议报告

世界卫生组织西太平洋和东南亚区域国家控制实验室(NCL)双区域网络自2018年以来每年举行会议,以增强NCL的自愿参与能力。其第七次会议由韩国食品药品安全部 (MFDS​​) 国家食品药品安全评价研究所 (NIFDS) 主办,与全球生物会议于 2022 年 9 月 6 日在首尔举行。超过 60 名与会者来自印度、印度尼西亚、日本、韩国、马来西亚、菲律宾、越南7个国家的代表现场和线上参加了会议。本次会议的主题是“疫苗和血浆衍生药品等生物制品的质量控制问题和国际趋势”。围绕生物制品质量控制体系分享了三场专题演讲,包括NCL在准备WHO列出的权威方面的考虑以及分享MFDS经验。此外,与会的 NCL 分享了与 COVID-19 大流行期间国家批签发相关的具体国家问题,并承认会议在应对大流行紧急情况的准备以及通过 NCL 之间的联盟和信息交流增强监管能力方面发挥着至关重要的作用。NIFDS将与其他亚洲NCL密切合作,加强生物制品质量控制,旨在通过合作建立区域标准并标准化检测方法。

更新日期:2023-10-04
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