1. What are the most critical and significant events in children? Which events lead to drug failures, withdrawals, regulatory warnings, or clinical guideline changes? What level of evidence is required to instigate these changes?
2. How do critical pediatric ADEs differ for low-income, disadvantaged, and/or minority populations? How does representation bias affect performance of AI/ML pediatric drug safety algorithms?
3. When do pediatric ADEs align with those found in adults? How do pediatric ADEs change over human development?
4. What are the common molecular mechanisms driving pediatric ADEs? What is the ontogeny of important pharmacogenes?