A flagship program: Virtual cGMP training marathon to build manufacturing workforce skills across all WHO regions
旗舰计划：虚拟cGMP培训马拉松，旨在培养所有WHO地区的制造业劳动力技能
For the sixth consecutive year, the World Health Organization (WHO) has successfully concluded its flagship global training event – the annual Virtual current Good Manufacturing Practices (cGMP) Training Marathon.
世界卫生组织(WHO)连续第六年圆满完成其旗舰全球培训活动——年度虚拟当前良好生产规范(cGMP)培训马拉松。
Conceptualised and launched in late 2020 during the COVID-19 pandemic by the Local Production and Assistance (LPA) Unit under the leadership of Dr. Jicui Dong, the training was leveraged on virtual platforms to meet the huge global demand for cGMP training as countries implemented travel restrictions and physical distancing measures, and access to training stood at a standstill. The Virtual cGMP Training Marathon employed an innovative approach to capacity building – sessions were delivered twice a week over several weeks to minimize interruptions in business operations and enable participants to translate new knowledge into practice immediately.
该培训在董继翠博士的领导下，由当地生产和援助（LPA）部门，于2020年底在COVID-19疫情期间构思并推出，在虚拟平台上利用该培训来满足全球对cGMP培训的巨大需求。这是因为各国实施旅行限制和物理距离措施，以及获得培训的机会陷入停滞。虚拟cGMP培训马拉松采用了创新的能力建设方法——在几周内每周举办两次会议，以最大限度地减少对业务运营的干扰，并使参与者能够立即将新知识转化为实践。
In 2020, the response was overwhelming. Over 6,000 participants from industry, national regulatory authorities and other stakeholders registered, representing more than 90 countries worldwide. Since then, the Virtual cGMP Training Marathon is an annual global training event to meet this global demand. Participation has grown with each Training Marathon - over 1,000 participants from manufacturers (pharmaceutical and biopharmaceutical), regulatory authorities and other stakeholders attended since 2020, to over 2,100 participants this year. More than 8,700 professionals from more than 80 countries across all WHO regions have been trained in total, with the largest proportion from the WHO African Region. Through this virtual approach, the Training Marathon has overcome geographical and financial barriers to participation, enabling equitable inclusion of professionals from low- and middle-income countries, and provided capacity building opportunities globally in a cost-efficient manner.
2020年，反响热烈。来自行业、国家监管机构和其他利益相关者的6,000多名参与者注册，代表全球90多个国家。从那时起，虚拟cGMP培训马拉松成为一年一度的全球培训活动，以满足这一全球需求。每次培训马拉松的参与人数都在增加——自2020年以来，来自制造商（制药和生物制药）、监管机构和其他利益相关者的1,000多名参与者参加了培训马拉松，今年的参与者超过2,100名。来自世卫组织所有区域80多个国家的8700多名专业人员接受了培训，其中来自世卫组织非洲区域的比例最大。通过这种虚拟方法，培训马拉松克服了参与的地理和财务障碍，使中低收入国家的专业人员能够公平参与，并以具有成本效益的方式在全球范围内提供了能力建设机会。
Dr Jicui Dong, Unit Head of the Product Policies, Access and Manufacturing Support (PAM) Unit (former Unit Head of the former LPA Unit), reflects:
产品政策、准入和制造支持（PAM）部门负责人（原LPA部门前负责人）董继翠博士反映：
“Over the past six years, the Virtual cGMP Training Marathon has become a global platform where professionals worldwide can build the knowledge and skills needed to ensure consistent product quality and regulatory compliance. We welcome new participants from around the world, alongside many who have joined us since the very beginning. The number and diversity of participants reflect a shared commitment globally to maintaining quality in manufacturing and protecting people’s health.
“在过去的六年里，虚拟cGMP培训马拉松已成为一个全球平台，世界各地的专业人士可以在这里积累确保一致的产品质量和法规合规性所需的知识和技能。我们欢迎来自世界各地的新参与者，以及许多从一开始就加入了我们的参与者。参与者的数量和多样性反映了全球对保持制造质量和保护人们健康的共同承诺。
I am grateful that the Virtual cGMP Training Marathon is becoming a cornerstone of our collective efforts to build resilient manufacturing capacity worldwide. It shows what is possible when we invest in people, reinforcing our shared goal of enabling every region to sustainably produce and access the quality assured health products it needs.”
我很感激虚拟cGMP培训马拉松正在成为我们在全球范围内建设弹性制造能力的集体努力的基石。它展示了当我们投资于人时会发生什么，强化了我们确保每个地区都能够可持续地生产和获得其所需的质量有保证的健康产品的共同目标。”
The Training Marathon has also evolved with each year, catering to the ever-changing global landscape. The inaugural Training Marathon laid the foundation with current WHO GMP guidelines and standards. In 2021, the curriculum focused on current WHO vaccine GMP as efforts to transfer technology and geo-diversify vaccine production ramped up globally. Each successive training marathon continued with progressively in-depth content and advanced GMP topics for quality production of vaccines as well as monoclonal antibodies, sterile products, and emerging platforms such as mRNA vaccines.
训练马拉松也逐年发展，以迎合不断变化的全球格局。首届培训马拉松为当前世卫组织GMP指南和标准奠定了基础。2021年，随着全球范围内技术转让和疫苗生产地域多元化的努力加大，课程重点关注当前的世卫组织疫苗GMP。每一次连续的马拉松培训都继续进行，内容和先进的GMP主题涉及疫苗以及单克隆抗体、无菌产品和新兴平台（如mRNA疫苗）的高质量生产。
The LPA Unit has also developed learning resource kits for participants and the wider global community. These Q&A-style resources capture real questions and on-the-ground issues raised during the Virtual cGMP Training Marathons, with expert peer-reviewed answers. They serve as a practical tool for continuous learning, sharing best practices and identifying potential solutions to real-world GMP issues. Kits from the 2021, 2022, and 2023 Virtual cGMP Training Marathons are already available, with the 2024 and 2025 editions to be published soon.
LPA股还为参与者和更广泛的全球社区开发了学习资源包。这些问答式资源捕捉了虚拟cGMP培训马拉松期间提出的真实问题和实地问题，并附有专家同行评审的答案。它们是持续学习、分享最佳实践和确定现实GMP问题潜在解决方案的实用工具。2021年、2022年和2023年虚拟cGMP培训马拉松的套件已经上市，2024年和2025年版本即将发布。
The Virtual cGMP Training Marathon is part of WHO’s ongoing work to strengthen and geo-diversify sustainable and scalable manufacturing capacities.
虚拟cGMP培训马拉松是世卫组织正在进行的加强可持续和可扩展制造能力并使其地域多样化工作的一部分。
The Virtual cGMP Training Marathon is a WHO flagship training program under one pillar of the WHO Biomanufacturing Workforce Training Initiative. launched in 2023. The other two pillars of the Initiative are:
虚拟cGMP培训马拉松是世卫组织生物制造劳动力培训倡议支柱下的世卫组织旗舰培训计划。2023年推出。该倡议的另外两个支柱是：
The Global Training Hub for Biomanufacturing (GTH-B) hosted by the Republic of Korea, and
由大韩民国主办的全球生物制造培训中心(GTH-B)，以及
A network of Regional Training Centres (RTCs) for the 6 WHO regions.
世卫组织6个区域的区域培训中心联办。
Together, the three pillars complement each other to synergise and increase access to capacity building for a skilled biomanufacturing workforce as countries and regions look to build and scale up manufacturing capacities.
随着各国及地区共同寻求建设和扩大制造能力，这三大支柱相辅相成，协同并增加熟练生物制造劳动力获得能力建设的机会。
Participants consistently highlight the Training Marathon’s practical relevance, technical clarity, and immediate applicability to real-world manufacturing challenges.
参与者不断强调马拉松培训的实际相关性、技术清晰度以及对现实制造挑战的直接适用性。
“The sessions provided precise, up-to-date guidance that we could apply immediately within our production lines. It has strengthened our internal quality systems significantly.” - Quality Assurance Officer, National Vaccine Manufacturer, Kenya, African Region
“这些会议为我们提供了准确、最新的并且可以立即在生产线中应用的指导。它显著加强了我们的内部质量体系。”-非洲区域肯尼亚国家疫苗制造商质量保证干事称道。
“The Training Marathon fosters a unique community of practice. The open dialogue with WHO experts on cGMP implementation has transformed how we approach compliance and continuous improvement.” - Regulatory Affairs Specialist, National Regulatory Authority, Brazil, Region of the Americas
“马拉松培训培养了一个独特的实践社区。与世卫组织专家就cGMP实施进行的公开对话改变了我们处理合规性和持续改进的方式。”-美洲区域巴西国家监管局监管事务专家称道。
“As our country expands local production capacity, this training has been essential for harmonizing knowledge and bridging experience gaps across teams.” - Production Lead, Emerging Vaccine Manufacturer, Egypt, Eastern Mediterranean Region
“随着我国扩大本地产能，这种培训对于协调知识和弥合团队之间的经验差距至关重要。”-埃及，东地中海地区生产负责人，新兴疫苗制造商称道。
“The Training Marathon has enabled our teams to align our manufacturing quality systems with international cGMP standards while also learning from peers in similar stages of production maturity. The continuity of this training over several years has been instrumental in supporting our progress toward regional self-reliance.” - Senior Specialist, National Regulatory Authority, Republic of Serbia, WHO European Region
“马拉松培训使我们的团队能够将我们的制造质量体系与国际cGMP标准保持一致，同时也向处于类似生产成熟度阶段的同行学习。多年来这种培训的连续性对于支持我们实现区域自力更生发挥了重要作用。”-世卫组织欧洲区域塞尔维亚共和国国家监管局高级专家称。
“This programme allowed us to align our manufacturing processes with international standards, while also learning from peers facing similar challenges across regions.” - Head of Bioprocessing, Public Biotherapeutics Institute, India, South-East Asia Region
“该计划使我们能够使我们的制造流程与国际标准保持一致，同时也向各地区面临类似挑战的同行学习。”-东南亚地区印度公共生物治疗研究所生物加工主管称。
“The training has delivered practical and timely guidance that we were able to apply directly to our regulatory inspections and dossier evaluations. Learning alongside peers from other regions and engaging with WHO experts has strengthened our institutional capacity.” - Senior Regulatory Officer, National Pharmaceutical Regulatory Agency (NPRA), Malaysia (Name withheld), WHO Western Pacific Region
“培训提供了实用且及时的指导，我们能够将其直接应用于我们的监管检查和档案评估。与其他地区的同行一起学习并与世卫组织专家合作增强了我们的机构能力。”-世卫组织西太平洋区域马来西亚国家药品监管局（NPRA）高级监管官员
For further information and inquiries about the Unit’s activities and initiatives, please visit the WHO website or contact localproduction@who.int.
关于该股活动和倡议的进一步信息和查询，请访问卫生组织网站或联系localproduction@who.int。
