Introduction to the Paediatric Investigation Plan Application

The workshop will familiarize participants with the EMEA's recently introduced guidance on the Paediatric Investigation Plan (PIP) Application, a new EMEA requirement designed to encourage and regulate the specific development of medicinal products for use in children. The workshop will cover: background information on the challenges associated with conducting paediatric development programs and the need for specific regulation; objectives of the new EMEA regulation; overview of the format and content of the documentation required for the PIP application. It will include a discussion of our hands-on experience with preparing a PIP application shortly after the regulation came into effect, illustrating the logistical challenges involved in obtaining the information needed at a time when little or no previous experience with this type of document was available.


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