Module232025

07/05/2025

Quality

Non-clinical studies

Clinical Studies

M&S

Study description and objectives

Study description, objectives and outcome measures Test system/species (age of the animal)

Study design features, main objectives and study population

Study description and objectives

Date of completion

Number of study participants by paediatric subset (e.g. age, sex, severity or stage)

Model Type

Duration of dosing

Duration of study (for participants

Data to be used to build the model

Route of administration

Dosage, treatment regimen and route of administration

Methodology

Date of initiation/completion

Control

Covariates

External Data Safety Monitoring Board

Model evaluation /qualification

Key evaluations and outcomes

Date of completion

Statistical plan Date of initiation/completion

The Organisation for Professionals in Regulatory Affairs

PIP Development

23

US iPSP content similarities and differences

• The content flow of the scientific documents are similar (e.g. molecule and disease background, summaries of data supporting paed development and description of planned studies) • The PIP template is more defined in terms of subheadings and content than for an iPSP • Generally, the content can be mapped between the two docs but more data may be available to be included in the iPSP as it should technically be submitted later in development (PIP submitted at beginning of adult phase 2, iPSP within 60 days of end-of-phase 2 meetings) • The iPSP does not have legally binding elements like the PIP, as the whole document is binding . Therefore, preferable to include less detail in the document

The Organisation for Professionals in Regulatory Affairs

PIP Development

24