Regulatory
High-Quality Surveys (HQS) under the MDR – A Concise Overview
High-Quality Surveys (HQS) are an elegant type of study, increasingly used by medical device manufacturers to support the Post-Market Clinical Follow-Up (PMCF) activities required by the European regulatory framework.
Machine versus human: Can Koda replace expert drug coders?
Exploring how WHODrug Koda performs in real‑world clinical data workflows: strengths, gaps, and what still requires human review.
IMPs vs. AxMPs: What’s the Difference and Why Does It Matter?
In clinical trials, distinguishing between Investigational Medicinal Products (IMPs) and Auxiliary Medicinal Products (AxMPs or AMPs) is essential for regulatory compliance, robust trial design, and patient safety.
Das neue Medizinforschungsgesetz: Was Stakeholder jetzt wissen müssen
Das Medizinforschungsgesetz (MFG) ist seit Ende Oktober 2024 in Kraft und bringt Neuerungen für alle, die mit der Entwicklung, Zulassung und Herstellung von Arzneimitteln und Medizinprodukten befasst sind.
Pitfalls in the clinical trial submission process according to CTR
On January 31, 2022, the long-awaited Clinical Trials Information System (CTIS) portal for submissions under the Clinical Trial Regulation (EU) No. 536/2014 (CTR) went online. Since then, many of us have already gained first experiences with the portal – especially since all new clinical trials now have to be submitted via this portal and the deadline for the transition to CTR of ongoing clinical trials is clearly approaching.
EU HTA Regulation: relevance, challenges and outlook
HTA stands for "Health Technology Assessment" and is used to systematically and transparently evaluate medical procedures and technologies from different perspectives. It aims to provide evidence-based information for physicians, health authorities, health insurers and patients.