CRED Successful and Skilful Communications 2025

Questions should be framed around organisation’s viewpoint and justification for this should be presented For example ● The company feels the following clinical trial endpoint is more appropriate because …. Does the authority agree with acceptability of this endpoint as proof of efficacy? ● Does panel agree that current clinical program will support registration of the desired indication in Europe Don’t ask open ended questions – be clear with questions Examples for questions

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The Organisation for Professionals in Regulatory Affairs

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Remember

Good communication is something that can be understood

Great communication is something that cannot be misunderstood

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The Organisation for Professionals in Regulatory Affairs

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