Module232025

07/05/2025

Section 4 – Proposed PIP

Existing data: • Should not be duplicated from IB but rather summarised and cross referenced • Data should also be put into context of relevance for paed development

Proposed development: • Need for proposed development put into

context of existing data and relevance for paed development • No need to repeat key elements table (see later slides) • Proposals must give suitable level of detail and justifications • Conservative approach must be given and support full paed development , measures can be later removed via modification if data doesn’t support proposal

The Organisation for Professionals in Regulatory Affairs

PIP Development

19

Section 4 – Proposed PIP

The Organisation for Professionals in Regulatory Affairs

PIP Development

20