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设计一个高效,可预测的全球批准后变化管理系统的方法,以促进持续改进和药物产品的可用性

Anders Vinther1, Emma Ramnarine2, Thierry Gastineau3

  • 1QBA - Quality Business Administration, San Carlos, CA, USA. anders@qbaleaders.com.

Therapeutic innovation & regulatory science
|February 18, 2024
PubMed
概括

全球监管的复杂性大大推迟了批准后的变化 (PAC),影响了药物供应. 一项新的倡议为行业和监管机构提出了8种整体方法,以确保全球及时提供药物.

关键词:
药物短缺问题 药物短缺问题对于批准后的变更,一个质量声音 (PAC的1VQ)经批准后的变化质量管理质量管理.监管的复杂性 监管的复杂性

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