CRED 8 Presentations

01/07/2024

 Talking to regulatory agencies

The Organisation for Professionals in Regulatory Affairs

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• Make sure that you submit the applications on the date as agreed with the NCA when asking for a submission slot/requesta submissionslot that is feasible for you • Ensure availability of relevant experts (especially when timelines are short, e.g. near the end of the procedure); • Respond to all questions / address all comments seriously/agreeon timelineswhen the NCAs will receive the responses • Be pro-active / anticipate; • If comments are not clear: consider requesting a clarification meeting. Recommendations

The Organisation for Professionals in Regulatory Affairs

48