Research Projects – University of Copenhagen

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Research Projects

With our research, we want to improve the drug regulatory system, by systematically studying its structure and behaviour as well as designing new tools to facilitate regulatory decision-making.

Through improvement of the drug regulatory system, we aim to contribute to an improvement of the health of the society. Furthermore, we carry out research that produces evidence to be used in drug regulatory decision-making.

Collaborative Projects

How best to protect public health: a comparative analysis of regulatory safety warnings on medicines in Australia, Canada the European Union and the United States.

Mintzes B, Roughead E, Lexchin J, Bero L, Dormuth C, Kesselheim A, Lipworth W, De Bruin ML, Gnjidic D, Puil L; National Health and Medical Research Council (NHMRC)/Project Grants.

University of Copenhagen (Copenhagen Centre for Regulatory Science) (DK), University of Sydney, University of South Australia (Aus), University of British Colombia and York University, Toronto (Ca), Harvard School of Public Health (US), King's College London (UK) and Utrecht University (NL).
Coordinator of the project, Dr Barbara Mintzes, University of Sidney

What works best to protect public health? An international comparison of post-market regulatory risk communication on prescription drugs.

Dormuth CR, Mintzes BJ, Sketris IS, Bero L, Davis C, De Bruin ML, Kesselheim A, Lexchin J, Mangin D, Moore TJ, Puli L, Roughead EE, Wiktorowicz ME; Canadian Institute of Health Research (CIHR). More details about the project (link).
Coordinator of the project, Colin Dormuth, University of British Columbia

Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU.

As a subcontractor to Utrecht University (NL), CORS participates through the Pharmacoepidemiology Research Collaboration Copenhagen  (co-investigator prof Morten Andersen) in this EMA requested multi-country study (EUPAS 16014)

Other ENCePP centres participating in the project are Univesity of Bordeaux (FR), Ludwig-Maximilians-Universitaet Muenchen (DE), Fundació Institut Català de Farmacologia (ES), Spanish Agency of medicines and medical devices (ES) and Aarhus University (DK).

PhD Projects

Factors ensuring effective Direct to Healthcare Professional Communication of Risk Mininization Initiatives

CORS funded project that aims to identify and understand the factors that determine the effectiveness of drug safety communication such as Direct to Healthcare Professional Communication and educational materials and sets out to present suggestions on how to improve the existing communication process.

Collaboration between the University of Copenhagen departments of Pharmacy (Health and Medical Sciences), Media, Cognition and Communication (Humanities) and Ferring Pharmaceuticals. Funding CORS partner: Ferring Pharmaceuticals. PhD candidate: Mathias Møllebæk (PhD Project Description).

The development of fixed-dose combinations (FDCs) through improved methodology

CORS funded project that will monitor and explore the conditions for the development of FDC’s taking into account the differences in the available data for categories.

Collaboration between the University of Copenhagen departments of Pharmacy; Drug Design and Pharmacology; Public Health (Health and Medical Sciences), and Contera Pharma. Funding CORS partner:Novo Nordisk. PhD candidate: Asbjørn Nøhr-Nielsen (PhD Project Description).

Similar but not identical: the changing regulatory landscape of biosimilars from the regulator, industry, professional, and patient perspectives

CORS funded project that aims to explore how different stakeholders interpret “similar,” and how these views impact the approval, development, and use of biosimilars.

Collaboration between the University of Copenhagen department of Pharmacy (Health and Medical Sciences) and the Centre for Advanced studies in Bio-medical Innovation Law (Faculty of Law). Funding CORS partner: LEO Pharma. PhD candidate Louise C. Druedahl (PhD Project Description)