Global Regulatory Affairs

A Paediatric Investigation Plan (PIP) is a development plan aimed at ensuring that the necessary data is obtained through studies on children, when it is safe to do so, to support the authorisation of a medicine for children.

The Paediatric Regulation which came into force in the European Union (EU) on 26 January 2007 dramatically changed the regulatory landscape of paediatric medicines in Europe.

We are in a strong position to offer you the highest level of experience in the design and writing up of Paediatric Investigation Plans (PIPs).

As an example of requirement, we can say that PIPs must cover the needs of all age groups of children, from birth to adolescence, but this is not the only requirement.

PIP Waivers

We can also assist with drafting justifications for a PIP Waiver. As some diseases do not affect children (for example Parkinson’s disease), the development of medicines for these diseases should not be conducted in children. In these cases, a PIP is not required and it will be waived.

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