by Barbara Van den Aarsen | Nov 12, 2025 | Uncategorized
What is a Paediatric Investigation Plan (PIP)? The European Medicines Agency (EMA) requires sponsors to follow Paediatric Investigation Plan (PIP) guidelines as part of the regulatory process for developing medicines intended for children. While other regulatory...
by Barbara Van den Aarsen | Sep 12, 2025 | Blog
Investigator-initiated clinical trials trials play an important role in advancing medical knowledge, exploring novel uses for existing therapies, and addressing clinically relevant questions that industry trials may overlook. However, these trials come with unique...
by Barbara Van den Aarsen | May 22, 2025 | Blog
Clinical trials play a vital role in developing new treatments and medications. However, when children are involved, the process becomes significantly more complex. Children are considered a vulnerable population, requiring careful ethical, regulatory, and...
by Barbara Van den Aarsen | Jan 9, 2025 | Blog
The main challenges encountered during clinical trials include patient recruitment and retention, but also regulatory hurdles and methodological complexities need to be overcome. Drug repurposing is one of the possibilities used by Orfenix that aims to ease the...
