Module232025

07/05/2025

Scientific document - general tips

• Scientific document template contains guidance text (in green) – read this and follow it! • Use relevant information that is of use to the assessors - balance between quantity and quality of information provided • Use recent references and reference to EU guidance and aspects where possible • Complete Section 1 – Application Summary last - much easier to summarise information that has been completed • Don’t use hyperlinks • Save formatting and references for the end of document authoring

The Organisation for Professionals in Regulatory Affairs

PIP Development

15

Section 2 - Overview of the disease(s), condition and pharmacological rationale

This section sets the scene

• Overview of product and condition • Discussion of differences between adults and paeds (also considerations of paed sub-sets) • Current methods used in paeds incl. off-label in proposed condition and EU authorised products used in the condition • Discussion of potential significant benefit of product in paeds • Linking the above to determine the proposed paed indication • High level summary of scientific advice and relevance to paeds • Feedback from networks, experts and patient groups

Can help to provide external justification for proposed strategy

The Organisation for Professionals in Regulatory Affairs

PIP Development

16