Blog
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.
Orphan Drugs in the process of the German Act on the Reform of the Market for Medicinal Products (AMNOG) – Quo Vadis?
The special position of Orphan Drugs in the process of the German Act on the Reform of the Market for Medicinal Products (AMNOG, Arzneimittelneuordnungsgesetz) is frequently criticized. In the following article, we will explain the concept of Orphan Drugs, elaborate their particular role and discuss the upcoming changes within the AMNOG process.
Artificial Intelligence (AI) in clinical research: transformation of clinical trials and status quo of regulations
Artificial Intelligence (AI) supported technologies play a crucial role in clinical research: For example, during the COVID-19 pandemic the Biotech Company BenevolentAI found through a machine-learning approach that the kinase inhibitor Baricitinib, commonly used to treat arthritis, could also improve COVID-19 outcomes.
EU CTR: How to write a good Lay Summary of clinical study results
Lay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research.
Simply explained: Drug approval procedures in Europe and the example of COVID-19 vaccines
Summary: There are three different marketing authorisation procedures in Europe: the Centralised Procedure (CP), the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).
Electronic informed consent (eConsent) in clinical research in Europe: opportunities and bottlenecks
While eConsent has become a reality in the US, Europe is still lagging behind in its implementation. To protect patient rights without compromising on the full potential of clinical research, flexible and dynamic consent formats will be crucial in the future.