PIPs/PSPs aim to describe in detail the research plan that will be carried out to evaluate the suitability of the investigational product in the paediatric population. They must ensure that sufficient data will be obtained to support their authorisation in children. In such a vulnerable population, it is crucial to align the intended objectives and expectations with the practical aspects of clinical development. With our experience, we will ensure that any potential issues that may arise are handled smoothly to achieve a comprehensive and successful application.