CRED Successful and Skilful Communications 2025

Where do you go for advice?

You want to discuss your primary endpoint for your proposed clinical study and the level of statistical advantage needed to show efficacy

Notified Body or Competent Authority or Consultancy or CRO

CRO

The Organisation for Professionals in Regulatory Affairs

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Where do you go for advice?

CMC for a new modified release formulation

To establish the “DESIGN SPACE” for its Quality Target Profile (QTPP) in pharmaceutical development (ICH Q8)

National CHMP or National Advice?

The Organisation for Professionals in Regulatory Affairs

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