Pharmakovigilanz in akademischen klinischen Prüfungen
Spezielle Erfordernisse und Abgrenzung zu industriegesponserten klinischen Prüfungen
europharm
Abstract
Pharmacovigilance in academic clinical trials – Special requirements and differentiation from industry sponsored clinical trials
Clinical research is driven by pharmaceutical industry and by academic sponsors. Although the regulatory requirements for pharmacovigilance in clinical trials are identically, the pharmacovigilance-related activities could be different due to the different goals (marketing authorization versus therapy optimization and drug repurposing) and available resources, financial, personnel and organizational. The article aims to present the possible differences and standards of pharmacovigilance-related activities initiated by academic sponsors from the perspective of practical experience.
 | Dr. med. Tanja Nickolay Studium der Humanmedizin an der Philipps-Universität Marburg: 2003–2010. Promotion an der Klinik für Neurologie der Philipps-Universität Marburg: 2011 mit dem Thema: „Im Landkreis Marburg-Biedenkopf, Evaluation der Epilepsiekosten in den verschiedenen Sektoren des Gesundheitssystems |
