CRED Understanding Clinical Development 2024

08/10/2024

Take home messages

PIPs are not small “regulatory add - ons”

They are a fundamental, mainstream aspect of product development

• Mandatory • Resource-intensive • Scientifically difficult to design • Politically challenging to negotiate with PDCO • Unpredictable in terms of outcome • Potentially very expensive to execute once agreed • A possible road-block to adult revenues

Easily the most difficult regulatory procedure in Europe outside of the MAA itself

The Organisation for Professionals in Regulatory Affairs

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Thank you

Questions…?

steve.pinder@envestia.com

The Organisation for Professionals in Regulatory Affairs

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