CRED Successful and Skilful Communications 2025

Regulators

• Are your key external gate-keepers • But the principles of this training can equally apply to dealing successfully with other external and internal stakeholders and customers

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The Organisation for Professionals in Regulatory Affairs

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With Regulatory Authorities: ● Advice on the Clinical Development Programme ● Eligibility for special designation such as PRIME or Orphan Drug ● Pack labelling/ SmPC wording (e.g. posology details) ● Shelf life ● Product name (applying umbrella branding) With colleagues: Negotiations in regulatory situations

● Submission timelines ● Data to be generated

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The Organisation for Professionals in Regulatory Affairs

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