Case study
Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage
A US based Biotech company was unaware of the EU’s requirement for a Pediatric Investigation Plan (PIP) until their product…
webinar
Paediatric Investigation Plan: Requirements, process, and comparison with US PSP
A Paediatric Investigation Plan is on the critical path to obtain market approval in Europe, even if the condition does…
publication
Optimising the Choice of the Condition for a Paediatric Investigation Plan
The “Condition” is typically a recognised distinct disease or syndrome that is the subject of a paediatric investigation plan (PIP)…
publication
Integrating the Paediatric Population within Global Drug Development
By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and…
publication
The First 10 Years of the European Paediatric Regulation
The conference, organized by TOPRA in collaboration with the European Commission (EC), was the opportunity to hear about the EC’s…
publication
Designing a CMC Strategy For Advanced Therapy Medicinal Products (ATMP) in EU
Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid…
publication
Development of orphan products and the impact of the EU Paediatric Regulation, TOPRA Vol 9,…
Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and…
publication
How to optimally integrate a Paediatric Investigation Plan into a drug development programs
For products falling under the mandatory scope of the centralised procedure, integrating a Paediatric Investigation Plan (PIP) into a company’s…
