CRED Understanding Clinical Development 2024

08/10/2024

IRIS portal

Guidance contains all the necessary instructions…

…but not necessarily in the right order !

The Organisation for Professionals in Regulatory Affairs

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Allow 12 months for the process

PIP review process

Submit

Validation

Consideration by PDCO

Agreement

Request for modification

Start again

Rejection

Agreement

Reconsideration by PDCO

Submit responses

The Organisation for Professionals in Regulatory Affairs

14

7