Originally aired: Tuesday, January 13, 2026
Duration: 60 minutes
Pediatric drug development is no longer optional, it is a critical component of global regulatory strategy and long-term product success. Regulatory agencies such as the FDA and EMA require early pediatric planning through Pediatric Study Plans (PSPs) and Pediatric Investigation Plans (PIPs), and these commitments directly influence development timelines, approvals, and market access.
This on-demand webinar brings together perspectives from industry, regulatory science, and academia to demonstrate how an integrated, model-informed approach can de-risk pediatric programs and support efficient development.
Speakers discuss:
- The clinical need and real-world challenges in pediatric populations
- Regulatory expectations and common pitfalls in clinical pharmacology gap analysis
- The role of Model-Informed Drug Development (MIDD)—including population pharmacokinetics/pharmacodynamics (PopPK/PD), physiologically based pharmacokinetic (PBPK) modeling, quantitative systems pharmacology (QSP), model-based meta-analysis (MBMA), and machine learning—in optimizing pediatric dose selection and streamlining development across modalities, from small molecules to biologics
- The session concludes with a panel discussion highlighting practical lessons learned and emerging trends shaping the future of pediatric drug development.
Key Learning Objectives
- After watching this on-demand webinar, participants will be able to:
- Explain why pediatric drug development is essential to both patient care and regulatory submission strategy
- Identify key regulatory requirements (PIP, PSP, ICH E11/E11A) and approaches to conducting a clinical pharmacology gap analysis
- Describe how pharmacometric tools (PopPK/PD, PBPK, QSP, MBMA) and machine learning can support pediatric dose prediction and study design
- Apply lessons from case studies across modalities—including small molecules, biologics, and advanced therapies—to their own development programs
