Module232025

07/05/2025

Strategic decisions for PIP

You can use publicly available PIP precedence to help inform your strategy

Consideration/Measure

Product X

Product Y

Product Z

Our product

Treatment of x

Treatment of x

Treatment of x with y mutations

Condition and Paed indication

Under 2 years

Under 2 years

Under 2 years

Waiver

Quality

Not applicable

Not applicable

Not applicable

Non-clinical

Juvenile tox study

Juvenile tox study

Juvenile tox study

Clinical

2 studies in ages..

2 studies in ages..

3 studies in ages..

Modelling & simulation

popPK study for dose finding

popPK study for dose finding

popPK study for dose finding

Extrapolation

Not applicable

Not applicable

Not applicable

The Organisation for Professionals in Regulatory Affairs

PIP Development

11

Mentimeter question:

What functions from your organisation are important to have input from when putting together the PIP strategy?

The Organisation for Professionals in Regulatory Affairs

PIP Development

12