Module 1 2021

01/07/2021

Medicines for children

• Maaike van Dartel, Dutch alternate PDCO member, MEB- CBB

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

• History, medicines in children;

Paediatric regulation;

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PDCO procedures;

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• Paediatrics in FDA and EMA;

• Challenges and possibilities;

The Organisation for Professionals in Regulatory Affairs

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