Module 1 2021

01/07/2021

Minimalize delays

• Be aware of the key binding elements when changing the study protocol • If necessary, request for PIP modification • Avoid problems at the moment of the compliance check

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Learning Outcomes: Recap

• Development of medicines for children is necessary • Paediatric development is mandatory in the EU for new medicines due to the paediatric regulation • PDCO and PIPs; • There are differences in requirements between FDA and EMA, but with joint meetings agreement on specific topics and needs is sought; • Collaboration is essential;

The Organisation for Professionals in Regulatory Affairs

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