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Introduction to the Paediatric Investigation Plan Application

Level:
Advanced
Area:
Drug Development
Code:
DDA10a
Duration:
03:30:00
Workshop profile:
Medical writers with a working knowledge of clinical drug development and some insight into CMC and nonclinical development. Experience writing IBs or IMPDs would be relevant.
Objective:
The workshop will familiarise participants with the EMA’s guidance on the Paediatric Investigation Plan (PIP) Application, providing a foundation that will be helpful for writing PIPs.
Content:
The PIP is an EMA requirement designed to encourage and regulate the specific development of medicinal products for use in children. The main elements of the workshop will be: • Background information on the challenges associated with conducting paediatric development programmes and the need for specific regulation • Objectives of the EMA regulation • Overview of the format and content of the documentation required for the PIP application. The workshop will include a discussion of hands-on experience with preparing PIP applications, illustrating some of the logistical challenges involved in obtaining the information needed from teams that often have little or no previous experience with this type of document. Participants will be encouraged to share any experience they may have had with organising or writing PIPs.