CRED Understanding Clinical Development 2024

08/10/2024

Compliance check

• There are two types of compliance check

Partial compliance check

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• Performed at time of MAA submission when some PIP measures are deferred

• Only the activities which are not deferred are compliance checked

Purpose is to allow MAA validation

•

Full compliance check

•

• Performed when all PIP measures have been completed

• Purpose is to allow collection of PIP-related incentives

Success requires each measure to be:

• Initiated no later than the agreed date • Completed no later than the agreed date • Performed exactly according to the PIP Decision

The Organisation for Professionals in Regulatory Affairs

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Learning outcomes recap

Legal framework

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Why children are different

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• Preferred approaches to clinical development in children

Devising PIP strategy

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• Content and format of a PIP

PIP review process

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Compliance checking

•

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