Spring Intro 2023

03/03/2023

Role of RMS ● Provide regulatory and scientific advice to the applicant ● Decides timetable ● Scientific assessment – assessment report ● Evaluates responses ● Central point between applicant and CMS ● Organises and chairs break-out sessions, instructs applicant ● Refers to CMDh ● Informs EMA if after referral no consensus ● Informs applicant and CMS after positive conclusion and prepares final assessment report ● Public assessment report

The Organisation for Professionals in Regulatory Affairs

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Choice of RMS may be dictated by: – Reputation – Relationship with applicant – Language – Willingness (especially with DCP) – Familiarity – Workload – Cost!!! Which RMS?

The Organisation for Professionals in Regulatory Affairs

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