Pharmacovigilance Research Center
Pharmacovigilance - the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine-related problems
Our research areas are:
- Proactive surveillance and signal detection using big healthcare data
- Multi-database network studies of rare adverse events
- Design of rapid risk evaluation systems
Pharmacovigilance is of major importance to the Danish society. As part of optimised treatment of patients with pharmaceutical interventions it is important to be aware of potential adverse drug reactions, how these can be detected and treated and ultimately how they potentially can be avoided.
The Pharmacovigilance Research Center is a Novo Nordisk Foundation funded initiative headed by Professor Morten Andersen. Our aim is to develop new methods and tools and generate new evidence that will shape future drug safety surveillance. Prospectively, our research will contribute to the evaluation of benefits/risks of therapy, and enable patients, healthcare professionals, regulators and the pharmaceutical industry to improve drug use and prevent drug-related problems for the benefit of public health.
We aspire to strengthen the field of pharmacovigilance as an academic discipline and create a truly interdisciplinary research field exploiting adjacent disciplines like pharmacy, regulatory science, and pharmacometrics, and benefiting from the tremendous resource of the Danish National Registers.
Members of the Pharmacovigilance research Group is currently organizing and teaching on the following courses:
Pharmacoepidemiology and Pharmacovigilance
Safety of Medicines - from Non-Clinical Development to Pharmacovigilance
Pharmacoepidemiology - Drug Use and Safety
Clinical Pharmacology and Biostatistics
Master thesis projects flyer (pdf)
As a Master’s thesis student at the PVRC you will be introduced to the field of pharmacoepidemiology, learn how to program in statistical software (SAS, Stata, or R), and become familiar with the opportunities of big healthcare data such our unique Danish Registries. We share our Pharmacoepi Computer Lab with the Pharmacometrics Group. Here you can perform your analyses and share knowledge with other students. We strongly encourage you to select our elective course Pharmacoepidemiology and Pharmacovigilance (block 3, C) and an individual study unit, which will provide you with basic knowledge of pharmacoepidemiological terminology and introduce you to the statistical software that you will use during your thesis. Other relevant course are Regulatory Science (block 4, C) and Design and Analysis of Experiments (block 3, B).
Find more information about Master projects within the Pharmacovigilance Reseach Center
Projects in geriatric Pharmacoepidemiology and Pharmacovigilance
- Comparison of misclassification of exposure among four methods used for computing the duration of pharmacological treatment episodes in secondary data sources.
- The relationship between the use of 5α-Reductase inhibitors, glucose intolerance, and type 2 diabetes mellitus.
- New insight on the safety of galcanezumab and fremenezumab: an analysis of spontaneous reports of adverse events recorded in the U.S. Food and Drug Administration Adverse Event Reporting System database.
Projects in Psychiatric Pharmacoepidemiology
- Risk of bleedings associated with combined treatment with selective serotonin-reuptake inhibitors and oral anticoagulants
- Cardiac-risk associated with long-acting antipsychotics in Schizophrenic patients
|Dorte Skytt Jensen||Special Consultant||+4535336277|
|Maurizio Sessa||Assistant Professor - Tenure Track||+4535337831|