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 team will discuss common issues that have impacted or delayed approvability in EU and US applications using illustrative case examples. The issues covered are dose selection, adequate pharmacokinetic (PK) data in target populations, adequate absorption distribution metabolism excretion (ADME) characterization and labeling recommendations for intrinsic and extrinsic factors, formulation changes, QT prolongation issues, and bioanalytics.
How did inadequate information impact regulatory decision-making and review outcomes in each case? What can we learn from others’ experience? In addition, commonly asked questions that arise for global programs with a focus on Japan and China will be presented.
By attending this webinar, you will learn.
- 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.
