Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of necessary clinical studies, maximizing available clinical data using model-informed drug development (MIDD) approaches, and expert communication of integrated information.
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.