CRED Understanding Clinical Development 2024

08/10/2024

When to submit your PIP

Nonclinical

Phase I

Phase II

Phase III

MAA

Phase IV

• PIP is due at Phase I / Phase II junction

• According to EMA website, submitting after initiation

of phase III trials (in any population) or after initiation of paediatric studies is likely to be considered unjustified

At this stage you have absolutely no idea about the effects of your drug in adults !

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PIP scope – the “PIP condition”

• PIP scope can be contentious: • PDCO wants to ensure that all possible paediatric uses are investigated • Industry often wants to focus only on targeted therapeutic indications • Mechanism of action is the key

• Ultimately PDCO has the right to decide on PIP scope

• A policy on PIP scope was published in July 2012 and revised in January 2024 (EMA/272931/2011) • The default scope is the corresponding MedDRA Higher Level Term (HLT)

with flexibility to go higher or lower as appropriate • Deviation from the default scope is very common

The Organisation for Professionals in Regulatory Affairs

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