医药行业如何构建以优化儿科药物开发？现有的儿科结构模型和对结构增强的建议。
How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.
机构信息
Global Drug Development, Novartis Pharma AG, Novartis Campus, 4002, Basel, Switzerland.
Global Regulatory Excellence, AstraZeneca, Paris, France.
出版信息
Ther Innov Regul Sci. 2020 Sep;54(5):1076-1084. doi: 10.1007/s43441-020-00116-4. Epub 2020 Feb 6.
BACKGROUND
Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development.
METHODS
The EFGCP Children's Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs.
RESULTS
Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified.
CONCLUSION
Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.
背景
欧洲和美国颁布的儿科法规打乱了制药行业的格局，挑战了商业和药物开发流程以及组织结构。在过去十年中，随着科学和创新的发展，行业已从被动转为主动，将投资用于建立适当的结构和能力，作为其业务战略的一部分，以更好地应对儿科药物开发的挑战和机遇。
方法
EFGCP 儿童药物工作组和 IQ 儿科工作组联手对其成员公司代表进行了调查，以了解制药公司如何组织以履行其监管义务并优化其儿科药物开发计划。
结果
确定了关键成功因素和建立适合用途的儿科专家组（PEG）的建议。
结论
儿科结构和专家组对于支持儿科药物开发的优化非常重要。
Zotero 插件