Module232025

07/05/2025

Documents to submit for restart: Upload in IRIS:  Document responding sufficiently to each point of the PDCO RfM, including reference list.

 Literature references (if previously not sent).  Supporting documents (if previously not sent).

- Make amendments to key elements directly in the IRIS portal - Consult the Key-elements-guidance

Do not send a modified scientific document.

The Organisation for Professionals in Regulatory Affairs

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Agenda

 GMA and implications for PIP Procedures  Scope of PIP  PIP approval  PIP opinion  Paediatric scientific advice  PIP modification, Stepwise PIP  Compliance check  PDCO PIP assessment, recurring issues

The Organisation for Professionals in Regulatory Affairs

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