Paediatric Investigation Plan (PIP)
- Due to recent legislation in the European Union governing the development and authorisation of medicines for use in children, a PIP now needs to be written, and an opinion adopted, prior to submission of a Marketing Authorisation Application.
- The preparation of a PIP presents the unique challenge of concisely presenting information on the disease to be treated in children and current knowledge of the drug being developed, together with assembling a convincing rationale for the paediatric development programme being proposed.
- In addition to lecturing on the writing of PIPs, Trilogy staff have accumulated extensive experience in the preparation of PIPs across a range of therapeutic areas.
- While writing a PIP, we advise our clients on this new type of document and proactively ensure that all the information needed from a diverse range of functions is brought together in a timely fashion.