Originally aired: Tuesday, December 2, 2025 | 11:00 am – 12:00 pm EST

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) increasingly expect pharmacometrics evidence to play a pivotal role in New Drug Application (NDA) and Biologics License Application (BLA) submissions. Initiatives such as the FDA’s Model-Informed Drug Development (MIDD) pilot underscore how analyses like population pharmacokinetics (PopPK) and exposure–response modeling have become essential for dose justification, variability assessment, and labeling decisions.

However, meeting these expectations can be challenging especially when submissions are expedited. Smaller and mid-sized biopharma companies often face limited resources and compressed timelines, while larger organizations must manage cross-functional coordination, evolving regulatory guidance, and global submission alignment. Sponsors are increasingly seeking strategies that balance scientific rigor with the practical realities of meeting regulatory deadlines.

In this on-demand webinar, Certara regulatory and pharmacometrics experts share practical insights into how sponsors can navigate these challenges. From understanding agency expectations to applying fit-for-purpose modeling approaches, you’ll gain actionable strategies to strengthen submission readiness, streamline workflows, and accelerate review timelines whether you’re operating in a lean biotech environment or across large, global R&D teams.

What you’ll learn

• Regulatory Readiness: Understand FDA, EMA, and global expectations for pharmacometrics evidence through early engagement and clear justification strategies.
• Core Analyses: Leverage population PK and exposure–response models to support dose selection, labeling, and benefit–risk decisions.
• Operational Challenges: Tackle evolving guidance, data complexity, and resource constraints with practical, proven solutions.
• Expedited Strategies: Manage compressed timelines with efficient, scientifically sound, and compliant modeling approaches.
• Future Outlook: Adopt integrated modeling, adaptive workflows, and clear visualization to strengthen next-generation submissions.

Speakers

• Felix Boakye-Agyeman MD PhD, Vice President, Consulting, Certara
• Huub Jan Kleijn, Sr. Director, Pharmacometrics, Certara
• Nolan Wood, PhD, VP, Clinical Pharmacology Consulting, Certara
• Rik de Greef, Senior Vice President, Global Quantitative Sciences Services, Certara