Paediatric Investigation Plan [PIP]« Back to Glossary Index
« Back to Glossary Index
- Paediatric medicine: Challenges of early developmentPaediatric medicine development requires careful planning and decision making. Legislation in the EU mandates that paediatric medicine development should occur early in the medicine development process.
- Paediatric medicine: Regulations and other influencersThe regulations governing paediatric medicine differ between the EU and the US.
- Paediatric medicine: Paediatric Investigation PlanA Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric development happens at the right time in the medicines development process. In special cases, the PIP can be waived.
- Mini-course starter kit – Protocol designThe starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day training on protocol design.
- Glossary: Period of Exclusivity