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
31
MRP/DCP -Practical Tips Choice of RMS/Change of RMS
The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs
32
Made with FlippingBook Ebook Creator