Module232025

Pediatric CMC: Perspectives and Final Remarks

Pediatric Drug Development Challenges:

▪ Few approved APIs, unclear regulations, small market profitability, and limited formulations/data for pediatric use. Barriers: ▪ High costs, low revenue, slower progress in Europe versus U.S./Asia, and economic/pharmacovigilance hurdles. Key Questions: ▪ Is pediatric medicine neglected? Are systems ready for personalized medicine and emerging therapies?

Conclusion: Collaboration, standardized frameworks, and QRM are crucial for improving pediatric CMC development and therapeutics.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs