CRED Successful and Skilful Communications 2025

Interactions with regulatory authorities/ gate keepers

• Do your homework on regulations and guidelines relevant to audience – What is the reason behind the interaction!! – Use legislation and regulations to your advantage – Obtain an understanding of any possible ‘political’ context, so you can “read between the lines”. • Interaction – Be respectful – Be prompt in responses. – Be prepared to lead the discussion (try not to follow)

The Organisation for Professionals in Regulatory Affairs

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Approach to Interactions

• Use the regulations and guidelines as justification of approach – Interpretation may be subjective, there is often more than one approach or justification – Regulations or guidelines may be new – Be prepared to discuss the regulation/ guideline as it pertains to your product – New regulations and guidelines are coming out all the time, as new products and new approaches are presented to the authorities, the old days of “This is how it’s always been done” is no longer applicable. Don’t accept it!!! ● Use the meetings and conversations as an opportunity to educate the authorities on your product – Don’t expect them to have built-in knowledge. – Understanding your product also means understanding your approach or response

The Organisation for Professionals in Regulatory Affairs

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