Module232025

07/05/2025

Importance of clock stop, continued High risk of negative opinion if PDCO request is not followed (and justification is bad). Use e.g., Experts/Enpr-EMA, Retrieve new data, Scientific Advice, Align with FDA requirements, Teleconference with EMA

The Organisation for Professionals in Regulatory Affairs

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Clock-stop and Teleconference

Ask EMA for a 1-hour teleconference to discuss/clarify PDCOs Request for Modification • w/ EMA coordinator, PDCO Rapporteur and Peer Reviewer. Not binding - can not take decisions on behalf of the PDCO. Highly recommended opportunity to discuss the PIP. • Especially when major changes to PIP/long clock stop • Burning issues like e.g. controversies on trial design can be discussed • EMA/PDCO representatives are those that know the PIP best – impact on PDCO. See: Procedural advice on paediatric applications

The Organisation for Professionals in Regulatory Affairs

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