A paediatric investigation plan (PIP), required in the European Union, or a paediatric study plan (PSP), required in the United States, is a development plan aimed at ensuring that the necessary data are obtained through clinical trials in the paediatric population.
Depending on which phase your product is in, our experts offer support to manage your PIP successfully.
When seeking marketing authorisation for new medicines, developers must include results from studies outlined in an agreed-upon paediatric development plan. This requirement also applies when adding new indications, pharmaceutical forms, or routes of administration to an already authorised medicine, unless a deferral or waiver has been granted.
These plans help support the authorisation of medicines for children by conducting studies specifically in paediatric patients.
With significant experience from global PIP projects, our experts help you succeed with your authorisation.
Arex offers supprt with:
– Paediatric plan development
– Paediatric plan writing
– Authority interactions
– Waiver management
– Scientific advice
– Project management
Clinical trials support and advice
Scientific advice support
Medical writing
Orphan product support
Erik Hedner
Arex Advisor AB
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Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.