CRED Successful and Skilful Communications 2025

Your turn What kinds of interactions with your regulators/ gatekeepers occur at the various points of time during life cycle of a regulated product?

Product Development

Post Approval

Approval

The Organisation for Professionals in Regulatory Affairs

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Why do regulators give guidance?

e.g. Dutch Medicines Evaluation Board (MEB) It is in the interest of patients, for applicants to generate a robust dataset that helps in the benefit/risk assessment To stimulate innovation and give guidance to companies, also small (national) companies Opportunity for assessors to get information on new developments in medicine development in early phase

The Organisation for Professionals in Regulatory Affairs

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