Module232025

07/05/2025

Own experience, Recruitment or timing difficulties

Tip: Make use of expertise e.g., from paediatric networks when planning the trial. Before study start, Trial Manager collects information from individual investigators on the feasibility of conducting the paediatric study as planned. If you face e.g., recruitment or timing difficulties with your study and you need to modify your PIP: Justify to PDCO that you have tried everything possible to fulfil the PIP: • Document the number of contacted centres/patients (i.e. how many out of the total paediatric patient population have been asked to participate?). • Provide reasons for investigators/patients refusing

The Organisation for Professionals in Regulatory Affairs

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• Consult ‘Other paediatric procedures’ in: Procedural advice on paediatric applications

Discontinuation of paediatric development?

TOPRA Paediatric course, 13 May 2025

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