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But …

… there can also be spontaneous interactions by phone, if you know your regulator and you want to have his/ her opinion or advice

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For your briefing you need to consider

Advice from your regulator is only as good as background information provided and questions posed Therefore, your briefing should ● make thinking visible – enable for the reviewer to follow the trail ● have a ‘story line’ that leads the reviewer to conclusions ● be comprehensive enough to put reviewer in a position to make a valid decision on company’s proposal – provide main arguments, clear justification and all necessary data ● be short enough – only information to support specific questions to be discussed – too much documentation only impedes meaningful and timely review of information ● be realistic, raise problems, if they exist

The Organisation for Professionals in Regulatory Affairs

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