一个混合方法评估,以确定行业知识需求和挑战在健康产品缺陷和召回报告在新加坡
Pei San Ang1, Michelle Sau Yuen Ng2, Desmond Chun Hwee Teo2
1Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01 Helios, Singapore, 138667, Singapore. ang_pei_san@hsa.gov.sg.
Drug safety
|April 24, 2025
概括
制药公司通过有针对性的培训改善了对健康产品缺陷报告和召回程序的理解. 这提高了合规性和公共卫生保护.
科学领域:
- 药品质量保证 药品质量保证 药品质量保证
- 监管合规性 监管合规性
- 公共卫生 公共卫生
背景情况:
- 医疗产品缺陷对质量标准和公共健康构成风险.
- 清晰的报告和缺陷管理对于制药行业至关重要.
- 新加坡卫生科学局评估了产品缺陷报告和召回方面的行业挑战.
研究的目的:
- 确定制药公司在产品缺陷报告和召回程序中的知识差距和挑战.
- 为行业专业人士制定有针对性的培训计划提供信息.
- 加强对健康产品安全的监管要求的遵守.
主要方法:
- 一种混合方法的方法,结合了在线调查和面对面的焦点小组讨论.
- 调查的目标是拥有注册药物,疫苗和细胞,组织和基因疗法产品 (CTGTP) 的公司的代表.
- 焦点小组包括一些已进行产品召回的公司;根据调查结果,开发了培训研讨会.
主要成果:
- 药物/疫苗的调查响应率为29.4%,CTGTP的响应率为57.1%.
- 参与者要求更明确的指导方针和缺陷报告示例,以帮助决策.
- 研讨会后的问卷测试显示,平均得分 (4.5%-25.0%) 和自我评价知识 (中位数为3至4) 均有所改善.
结论:
- 评估证实,通过调查,重点小组和培训,对监管要求的理解得到了增强.
- 倡议为行业提供了知识,以便做出明智的决策并改善合规性.
- 调查结果将用于简化缺陷和召回流程,以获得更好的公共卫生结果.
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