Spring Intro 2023

30/03/2023

External • PDCO • PIP coordinator, Rapporteur and Peer Reviewer EU Paediatric Committee within the EMA (PDCO) – Responsible for review/approval of paediatric development programme for a medicine – Consists of: • Members nominated from within CHMP • Members nominated by EU Member States (each country’s agency) • Members representing patients’ organisations • Members representing healthcare professionals’ organisations → Includes many academics as well as regulatory staff – The PDCO need to agree the PIP/Waiver/Deferral • The agreed plan is binding on the company • Published on EMA website Top Tip – The PIP Coordinator IS key – build relationships Who – External ?

The Organisation for Professionals in Regulatory Affairs

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Paediatrics

What ? • Paediatric Investigation Plans, PIP modifications, PIP Compliance checks Why ? • Mandatory activity in Europe (no PIP = no MAA) • Completed PIP = Supplementary IP protection When ? • End of Adult PK/ around proof of concept • Modifications throughout lifecycle • Compliance check prior to MAA, line extensions and PIP completion • Top tip: Engage + educate internal teams early How + Where ? • Formal defined submission route with EU regulators (PDCO) Who ? • Internal – Formulation development, Nonclinical, Clinical, Clinical pharmacology • External - PDCO

The Organisation for Professionals in Regulatory Affairs

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