Module232025

Learning Objectives 1. Our Framework for REG CMC AND Pediatric Drug Development - a Market on the move

2. Strategic Considerations for Pediatric Development: When should pediatric CMC development start?

3. Reference to Legislative/Regulatory Frameworks and Resources of Procedures/Guidance

4. Formulation of pediatric Drugs – from Scalability to Patient compliance.

5. Challenges in Drug Development for Pediatric Patients

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API/DS

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ADME & Tox in pediatric patients

▪ Administration Route and Pharmaceutical Dosage Forms

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Pediatric Patient Acceptability / Compliance

6. Examples and Solutions for ped. CMC Development Constraints 7. ATMPs etc. , Ped. CMC Development Future Perspectives and Final Remarks

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs

https://allurepharm.com/pediatric-medications/