Module232025

07/05/2025

Section 5 – Timelines and deferrals

• Table to be completed with proposed measures and timelines • Completion of studies should correspond to study reports • Think carefully about timing between data availability and start of proposed studies; studies should not be delayed without justification • Timelines should align with previous diagram to put overall adult and paed development into context • Deferrals discussed and justified here in line with proposed MAA submission date

The Organisation for Professionals in Regulatory Affairs

PIP Development

21

Key elements

• Key elements are the specifics of proposed measures that become legally binding • The eventual approved key elements forms the minimum that an organisation is required to do to support paediatric development • Think carefully about what is added to the proposed key elements!! • Used to be a separate form, now part of IRIS application • EMA has guidance on details needed for measures in the key elements: • NOTE: some IRIS key element sections have changed from previous guidance – modifications submitted to previously agreed KBE may not directly align

The Organisation for Professionals in Regulatory Affairs

PIP Development

22