CRED Understanding Clinical Development 2024

08/10/2024

Importance of the KEF

• The KEF is the most critical of all the aspects

• Forms the basis of the EMA Decision…

• …which is the definitive version of the agreed PIP from a legal perspective…

• …and so it represents the company’s legal obligations…

• …and is the basis for the compliance check…

• …which must be passed before an MAA can be validated

The Organisation for Professionals in Regulatory Affairs

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PIP submission

iris.ema.europa.eu

• Electronic submission via a EMA’s IRIS portal is mandatory

Prerequisites:

•

• Applicant company details present in OMS database

• Drug substance has an RPI

• At least 1 person has IRIS INDUSTRY USER ADMIN status at the company

• The person operating the portal has been assigned IRIS INDUSRTY MANAGER or IRIS INDUSTRY CONTRIBUTOR status… • …on behalf of that specific applicant

The Organisation for Professionals in Regulatory Affairs

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