临床药理信息占药品说明书的 50% 以上。不完善的临床药理开发计划会导致申办方在审评期间遇到重大问题，或影响其上市申请的批准。要对上市申请进行高效的临床药理审评，就必须尽早对开发计划进行深思熟虑的考量，及时开展必要的临床研究，使用模型引导的药物开发 (MIDD）方法最大限度地利用现有的临床数据，并对综合信息进行专业沟通。
As former FDA and EMA regulators, the Certara Clinical Pharmacology Regulatory Strategy Team has extensive understanding of the requirements for fit-for-purpose clinical pharmacology drug development programs. The objective of this webinar is to review the clinical pharmacology-related regulatory hurdles across regions that may lead to review issues or impact approvability of marketing applications and discuss strategies to mitigate these.
The Certara team will discuss:
- How overly minimalistic clinical pharmacology documentation can jeopardize your drug’s approvability.
- Regulatory perspectives on gaps in clinical pharmacology knowledge and how those impact risk-benefit assessments
- Mitigation strategies to achieve a streamlined clinical pharmacology strategic plan.
