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质量和安全的最高标准

我们相信每个患者都应该得到及时、高质量、安全的药物.



十博10bet国际网页版知道病人和顾客的健康依赖于质量和安全的文化. We prioritize our patients and customers and hold ourselves to the highest standards of quality and safety. This means using advanced technologies and control measures to manage and mitigate risk at every stage of drug discovery, development, manufacturing and delivery.

我们的内部和外部安全系统是按照最高标准管理的. 我们与顶尖的学术科学家合作, 卫生部门和行业同行 to ensure we not only adhere to the highest standards, 而是积极推进药品质量安全领域.

Product quality

We have robust systems in place to ensure the medicines we manufacture are high quality and available when patients need them. 我们的质量委员会监督我们的质量战略,并直接对我们的首席执行官负责. 专家团队监督我们流程的每个方面, 从发现和开发到制造和交付. 

除内部控制措施外, our quality processes are reviewed, 由多个外部监管机构和被通知方认证和审计. We use an integrated enterprise quality management system that complies with all applicable global standards and regulations (GxP) from the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA) and other leading standard organizations.  

Supply assurance

Our assurance of supply program is designed to help us maintain supply of medicines for our patients who rely on them. Even in unpredictable circumstances, 例如在COVID-19大流行期间, 我们确保我们的病人继续得到不间断的药品供应. 这包括确定和确认备用供应商, 扫描环境,发现潜在风险,进行场景规划.

为了确保我们供应链的质量和完整性,我们有一个 supply chain management system that includes criticality assessment, controls, relationship management and continuous monitoring.

Patient safety

Our safety team of physicians and scientists are recognized experts both within and beyond AbbVie. 与学术科学家合作, 卫生部门和行业同行, 我们都积极推进药品安全领域. Our integrated, multi-disciplinary approach and advanced technologies are designed to identify potential safety signals early and minimize risk. 我们不断地进步知识, 安全团队的技能和效率, 来自那些从事药物开发的人, to those interacting with patients.

Our beliefs in action

从我们的临床试验到我们的市场产品, 我们的做法反映了对患者安全的深切承诺:
 

  • AbbVie was a leading adopter of the 2015 FDA Safety Assessment Committee recommendations for clinical trials, establishing an internal Safety Committee to advise and monitor two strategic clinical development programs.
  •  We comply with Good Clinical Practice, 帮助确保安全的全球标准, 试验设计中试验的完整性和质量, 执行情况和结果报告.
  • 我们的产品标签和包装是根据患者的需求开发的. We conduct in-depth research to understand patient preferences and behaviors to ensure that dosage instructions are clear to prevent accidental misuse. 
  • We maintain a robust pharmacovigilance program once our medicines are approved and marketed. Our advanced post-marketing surveillance systems detect and address potential safety signals quickly.
  • Our safety experts 都是药物警戒领域的领头人. 他们编辑并为这本塑造行业的书做出了重大贡献, 药物警戒:一种实用的方法.”

在十博10bet国际网页版,科学的进步不止于药物. Our safety scientists are continually advancing both theory and practice in the field of patient safety. 请参阅他们的一些出版物,并了解更多十博10bet的方法:

Writing the book on pharmacovigilance to advance a public health approach to patient safety.

通过整合认知系统和行为系统推动安全科学领域的发展, medical assessment, and data science.

Supporting evidence based best-practices for prescription drug labelling and educational materials.

98%

我们经常达到98%以上的及时性,加速报告不良事件到美国.S. 食品和药物管理局(FDA)和欧洲药品管理局(EMA)  

For the Well-Being of Our Patients