Farma

In september 2024 gooide ik het roer volledig om: na meer dan vijf jaar in de vertrouwde omgeving van de zorg en klinische studies besloot ik me te wagen aan kwaliteitsbeheer, een vakgebied waar ik nauwelijks iets van afwist, maar dat me meteen fascineerde. Als beginnend QA-consultant bij een distributiebedrijf van medische hulpmiddelen kreeg ik […]

By the end of this month (31st of January 2025), the final deadline is reached in the transition period for the implementation of the European Clinical Trial Regulation (EU-CTR). What is it and what is the difference with the previous European Clinical Trial Directive (EU-CTD)? First, let’s explain the difference between a European “Regulation” and

Effective Project Management in the Pharmaceutical Industry: Tips and Tricks for Success In the complex and highly regulated world of the pharmaceutical industry, project management plays a pivotal role to bring life-saving medications and treatments to the market. From drug discovery to clinical trials and regulatory approval, effective project management is essential for managing timelines,

Radiopharmaceutical and selective internal radiation treatments have emerged as a transformative force in the pharmaceutical industry, offering precision, personalized therapies for patients with conditions such as cancer and other serious diseases. These innovative treatments combine radioactive isotopes with specific compounds that bind to e.g. tumor cells to deliver precise doses of radiation directly to diseased

Since the implementation of the Medical Device Regulation (MDR) in Europe, companies have had to maintain and execute a post-marketing surveillance (PMS) procedure. This systematic process involves collecting and analysing data on the performance and safety of medical devices after they have been released to the market. The primary goal is to help manufacturers identify

In de farmaceutische industrie is de kwaliteit van producten van vitaal belang. Dit geldt in het bijzonder voor medicinale producten die gevoelig zijn voor temperatuurfluctuaties, zoals vaccins, biologische producten, en bepaalde geneesmiddelen die in een gecontroleerde omgeving moeten worden bewaard en getransporteerd. Binnen dit proces speelt de CQV (Commissioning, Qualification, and Validation) expert een cruciale