Gwaza Luther, Chemwolo Andrew, Musonda Mario, Kuwana Rutendo, Dube Admire
Health Products Policy and Standards Department, Access to Medicines and Health Products Division, World Health Organization, Geneva, Switzerland.
Regulation and Prequalification Department, Access to Medicines and Health Products Division, World Health Organization, Geneva, Switzerland.
Front Med (Lausanne). 2024 Apr 11;11:1394562. doi: 10.3389/fmed.2024.1394562. eCollection 2024.
Having a robust, integrated regulatory system is important for ensuring the availability of safe and efficacious medical products of good quality and for protecting public health. However, less than 30% of countries globally have reached the required regulatory maturity level three, with low- and middle-income countries facing challenges in attracting and retaining qualified staff. World Health Organization (WHO) advocates for systematic workforce development, including competency-based education, to address these gaps. We provide perspectives on a systematic approach to capacity building of medicine regulators based on the experience and lessons learnt in developing and piloting the WHO global competency framework for medicine regulators through three scenarios. A systematic approach to capacity building, such as the human performance technology model, can be used to implement the WHO competency framework as part of organizational performance improvement while ensuring that initiatives are well-defined, targeted, and aligned with organizational goals. The competency framework can be used in different contexts, such as improving organization performance for individual regulatory authorities, strengthening regional collaborations, harmonization and reliance on medical products assessment and joint good manufacturing practices inspections of pharmaceutical manufacturers, and developing learning programs for medicine regulators. A competency-based learning approach for regulatory professionals ensures the transfer of learning to the workplace by integrating real-world practices in learning activities and assessments. Further work is required to develop and validate the assessment instruments, apply the competency framework in other contexts, expanding the learning programmes while continuously providing feedback for further refinement of the competency framework and implementation support tools.
拥有一个强大、综合的监管体系对于确保安全、有效的优质医疗产品的可及性以及保护公众健康至关重要。然而，全球不到30%的国家达到了所需的监管成熟度三级水平，低收入和中等收入国家在吸引和留住合格工作人员方面面临挑战。世界卫生组织（WHO）倡导进行系统的劳动力发展，包括基于能力的教育，以弥补这些差距。我们通过三个案例，基于在制定和试行WHO药品监管人员全球能力框架过程中获得的经验和教训，就药品监管人员能力建设的系统方法提供观点。一种能力建设的系统方法，如人力绩效技术模型，可用于实施WHO能力框架，作为组织绩效改进的一部分，同时确保各项举措定义明确、目标明确，并与组织目标保持一致。该能力框架可用于不同情境，如提高单个监管机构的组织绩效、加强区域合作、协调和依赖医疗产品评估以及对制药商的药品生产质量管理规范联合检查，以及为药品监管人员制定学习计划。基于能力的监管专业人员学习方法通过将实际工作实践融入学习活动和评估中，确保学习能够转化到工作场所。还需要进一步开展工作来开发和验证评估工具，在其他情境中应用该能力框架，扩展学习计划，同时持续提供反馈以进一步完善能力框架和实施支持工具。
