Spring Intro 2023

30/03/2023

Key point to remember

A clear definition (and company agreement on this) of the target paediatric population is essential – condition and indication

• This may not be the same as the adult population… • May be either a broader or more focussed population • You may need to justify NOT investigating in other populations • Consider Medical Dictionary of Regulatory Activities (MeDRA) high level term versus lower level term

e.g. of MeDRA – High level term of fibrosis

The Organisation for Professionals in Regulatory Affairs

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Key point to remember

Try to ensure alignment of EU and US paediatric development strategies.

• EU PIP and US PSP may or may not be filed in parallel (often PIP is filed first) • PDCO and FDA feedback is not always aligned (although there are cross agency discussions)

The Organisation for Professionals in Regulatory Affairs

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