Module232025

07/05/2025

Short, simple and precise...!

Don´t include too much information in the key elements form ● Will become the binding PIP opinion, which must be followed to get a positive compliance check! Keep it short, ”bullet-point-style”, simple - only include essential parts! No background, explanations, justifications, legal requirements (e.g., consent), detailed information Make extremely precise and concrete phrasings – minimise risk of differing interpretations!

The Organisation for Professionals in Regulatory Affairs

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KEF includes guidance text proposals and allows for some degree of flexibility

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