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Further considerations on your briefing

• Regulators will answer ONLY questions that you ask • Don’t ask unless you’re ready to accept advice and amend plans • If it is vital to know answer, ask question DIRECTLY • Company’s rationale for each question is key • Advice is restricted to purely scientific issues • Know guidelines – but don’t feel tied by them • Don’t ask questions where information is readily available in guidelines - interpretation questions can be raised • Purpose is not to check whether what you have done is acceptable ... ASK BEFORE, NOT AFTER • Don’t try to resolve internal company arguments

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Most common questions in briefings for medicines are …

• Wording of proposed indication • Study design / demonstration of efficacy / endpoints / statistical and interim analysis plans • Size of patient safety database / duration of studies

• Proposed comparators • Manufacturing issues • Risk management plan

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