CRED 8 Presentations

08/07/2024

MRP/DCP -Practical Tips Choice of RMS/Change of RMS Initial selection based on :

● RMS that is supportive and coordinate the procedures amongst other CMSs ● Particular areas of expertise ● Knowledge of RMS preferences and issues based on previous applications ● Perceived strength of certain Health Authorities ● Slot availability ● Proactivity during validation period ● Duration of clock-stop Change of RMS ● Possible ● Driven by MAH with adequate justification – Cannot occur during procedure – The MAH should get agreement of current and future RMS prior to notify of the change ● Driven by RMS/CMS – Cannot be agreed without MAH consultation

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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MRP/DCP -Practical Tips Choice of RMS/Change of RMS

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

32