by Hellen Houlleberghs | Jul 27, 2026 | Webinar
Webinar: How do you design a clinical study that is registration-ready? 13 October 2026, 16:00 CEST Register here Learn how to design a registration-ready clinical study. Built for approval, built for patient access. After this session you will: Clearly understand...
by Hellen Houlleberghs | Nov 12, 2025 | Blog
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 Hellen Houlleberghs | 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 Hellen Houlleberghs | Jun 17, 2025 | Blog
A promising rare disease treatment supported by Orfenix. At Orfenix, we are dedicated to turning academic breakthroughs into life-changing therapies through efficient and socially responsible drug development. One of our key projects focuses on guanabenz, a promising...
by Hellen Houlleberghs | 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...
