Education
CORS is involved in this part-time continuous education programme, given at the University of Copenhagen. The Master's programme offers an opportunity to get thorough insight into the regulatory process at all the stages during drug development, as well as highlight the differences in regulatory demands that are present between countries.
We contribute to the following courses:
- Drug Regulatory Science
- Global Pharmaceutical Policy - Rationales and Stakeholders
- Labelling as a Driver for Regulatory Strategy
- Safety of Medicines – from Non-clinical Development to Pharmacovigilance
- Transparency and Trustworthiness in Drug Development
All the staff of CORS is directly involved with teaching, along with members of our Scientific Advisory Board and invited speakrs.
Find out more about the Master of Medicines Regulatory Affairs
This course is an elective for the MSc Programme in Pharmacy or Pharmaceutical Sciences, the MSc Programme in Medicinal Chemistry, and the MSc Programme in Pharmaceutical Sciences (English programme). The aim of the course is to give participants insight into and understanding of Regulatory Science as well as giving the participants a better understanding of the theories and methods available for analysing the effects of regulatory systems and interventions.
CORS supervises theses of students in the process of finishing their master degree.
Are you considering joining us? Read the Master Thesis Catalogue to find out about potential master projects.
Several projects of our previous Master students have resulted in publications and posters. See some of the outcomes:
In published articles:
- New Information on Old Medicinal Products: A Cross-Sectional Analysis of Guidance for Paediatric Use for Substances on the European Priority List of Off-Patent Medicinal Products
DOI: 10.1007/s40272-022-00530-1 -
Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018
Højer MG, De Bruin ML, Boskovic A, Hallgreen E C.
BMJ Open 2020;10:e036498.
doi: 10.1136/bmjopen-2019-036498 -
Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency between 2014 and 2017
Marc Maliepaard Timi Toiviainen Marieke L. De Bruin Didier Meulendijks
Clinical Pharmacology
https://doi.org/10.1002/cpt.1834 -
Katerina M. Mantila, Anna M.G. Pasmooij, Christine Erikstrup Hallgreen, Peter G.M. Mol, Job F.M. van Boven
In Posters:
- Marketing authorisation pathways and clinical evidence supporting approval of orphan medicinal products in EU between January 2015 and October 2021
- Impact of the Intensified Reporting Requirements on reporting of suspected side effects of new pharmacological products in Denmark
- Impact of the 2012 pharmacovigilance legislation on the harmonisation of DHPCs in the EU
- The Impact of the new pharmacovigilance legislation on the harmonisation of direct healthcare professional communications across Europe