Section 1: From past to current needs in pediatric drug research 1. Preface: overview of pediatric drug development and pharmacovigilance 2. Historical perspective 3. Parents' and children's needs in the drug development process 4. The needs from the regulatory authorities' perspective - current status and worldwide initiatives 5. Optimal pediatric therapeutic development - the partnership between patients/families/industry and academia: the pharmaceutical industry's perspective 6. The needs, challenges and opportunities from the academic researchers' perspective 7. The needs from a health care provider's perspective Section 2: Designing pediatric drug research: from bench to bedside and back 8.
Application of in vitro models 9. Application of preclinical juvenile animal models 10. Application of pediatric adapted modelling and simulation approaches 11. The promise of omics approaches for pediatric drug development 12. Generation and interpretation of big data in pediatric drug development 13. Investigational Medicinal Product considerations in pediatric clinical drug trials 14. Co-designing pediatric clinical trials with multi-stakeholders: a step by step approach Section 3: Improving the performance of pediatric drug research: big changes start with small steps 15. Principles of performing pediatric clinical drug trials 16.
Regulatory considerations in the design and conduct of pediatric clinical trials 17. Ethical considerations in the design and conduct of pediatric clinical trials 18. Performing clinical drug trials in acute and critically ill neonates and children 19. Performing clinical drug trials in children with a rare disease 20. Policy of pediatric oncology drug development 21. Practice of pediatric oncology drug development 22. Pediatric drug formulations 23. Worldwide network initiatives in improving pediatric drug research 24.
The patients'/parents' voice within pediatric drug research 25. Pediatric drug development issues during public health emergencies Section 4: Future perspectives in pediatric drug research: the road to better drugs for children 26. Future of pediatric drug research from different stakeholder perspectives.