CRED Successful and Skilful Communications 2025

Common mistakes observed are …

• Having interactions without a clear understanding of your regulator, i.e. not having done the appropriate “homework” • Having no clear messages or the right questions to ask. Your regulators are not your “regulatory consultant.” You need to to know your drug, your patient population, and your plan • Ignoring/ arguing with your regulators or their requests. The regulators usually tell you – or strongly hint at – what they want. Companies sometimes have “selective hearing” or “selective memory” • Going “over the head” of your regulators is usually NOT a good idea! Regardless of the outcome, it can cause long term damage with the relationship

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Key learning outcomes on meetings with regulators

1. Principles for best way to organise and prepare for your internal or external interaction 2. Feel confident in how to present your case, to make your point and use your time efficiently 3. Get prior advice/ feedback on your negotiating approach (WEB, WAP and Tradeables) 4. Understand the necessity of a fall-back strategy and obtain buy in from internal partners 5. Know how to select and manage your delegation for achieving the best chance of success 6. Understand the view of the Authority (their WEB)

The Organisation for Professionals in Regulatory Affairs

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