Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2023-10-03 DOI:10.1016/j.biologicals.2023.101712
Sun Bo Shim , Chan Woong Choi , Jin Ho Shin , Jong Won Kim , Silke Schepelmann , Jae Ho Jung , Harish Chander , Ratih Pujilestari , Madoka Kuramitsu , Masaki Ochiai , Nee Yuan Qi , Geraldine N. Dimapilis , Luu Thi Dung , Hyung Sil Moon , In Soo Shin
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Abstract

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.

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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。
自2018年以来,世界卫生组织西太平洋和东南亚地区的国家控制实验室双区域网络每年举行一次会议,以提高国家控制实验室的自愿参与能力。其第七次会议由食品药品安全部韩国国家食品药品安全评估研究所(NIFDS)主办,并于2022年9月6日在首尔举行了全球生物大会。来自七个国家(印度、印度尼西亚、日本、韩国、马来西亚、菲律宾和越南)的60多名与会者现场和在线出席了会议。这次会议的主题是“包括疫苗和血浆衍生药物在内的生物制品的质量控制问题和国际趋势”就分享生物制品的质量控制系统发表了三次特别演讲,包括非传染性疾病在准备世界卫生组织上市机构和分享MFDS经验时的考虑。此外,与会的非传染性疾病专家分享了新冠肺炎大流行期间与国家批量释放有关的具体国家问题,并承认会议在应对大流行紧急情况和通过非传染性疾病之间的联盟和信息交流加强监管能力方面的关键作用。NIFDS将与其他亚洲NCL密切合作,加强生物产品质量控制,旨在通过合作建立地区标准和标准化检测方法。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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