监管事务的创新方法:利用人工智能和机器学习来实现有效的合规和决策
C S Ajmal1, Sravani Yerram1, V Abishek1
1Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, Telangana, India.
The AAPS journal
|January 8, 2025
概括
人工智能 (AI) 和机器学习 (ML) 正在通过自动化任务和加速药物批准来彻底改变制药监管事务. 然而,人工智能验证,数据安全和伦理方面的挑战需要谨慎管理才能成功整合.
科学领域:
- 制药科学 制药科学
- 监管事务 监管事务
- 计算机科学 计算机科学
背景情况:
- 人工智能 (AI) 和机器学习 (ML) 正在越来越多地影响各种行业,其中制药行业是主要受益者.
- 制药行业正在利用AI/ML来提高监管流程的效率和速度.
研究的目的:
- 探索AI和ML对制药监管事务的影响,包括档案准备,提交和合规.
- 检查将AI/ML技术整合到监管实践中的好处和挑战.
主要方法:
- 审查目前在制药监管事务中使用的基于人工智能的工具.
- 分析AI/ML在监管工作流程中的优势和障碍.
- 讨论与监管机构合作的必要性和适应不断变化的框架.
主要成果:
- 通过自动化耗时任务,AI/ML技术简化了工作流程,加快了结果,并缩短了产品审批时间表.
- 目前的人工智能工具,如DocShifter,Veeva Vault等,正在被监管专业人士积极使用.
- 重要挑战包括人工智能软件验证,数据安全,隐私,潜在的偏见,道德问题和变化管理.
结论:
- 人工智能整合有望从根本上重塑监管流程,加快安全有效药品的批准.
- 与监管机构的积极合作和适应新技术对于管理AI/ML采用至关重要.
- 在监管事务中,AI/ML的标准化协议仍在美国FDA,EMA和MHRA等机构的开发中.
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