CRED Successful and Skilful Communications 2025

When you receive regulator’s minutes …

• Review them to ensure accuracy – They are the official minutes – They give opportunity to clarify meaning of regulator’s advice that is perceived as being not clear, ambiguous or precise enough – In EU procedures - clarifications will be addressed in writing by coordinators if minor, by SAWP if major ● Promptly follow-up on any regulator’s requests from meeting ● Seriously consider recommendations and suggestions – Regulators have seen issues with other products that they can’t discuss with you – Not taking advice into account may expose you to criticism at time of submission/assessment

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The Organisation for Professionals in Regulatory Affairs

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If discordance with advice cannot be resolved

• Risk of not following advice needs to be evaluated and documented • Scientific justification needs to be prepared • If you receive an adverse opinion, consider appealing, but only IF you have a strong scientific and regulatory case

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The Organisation for Professionals in Regulatory Affairs

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