Newest issue of Regulatory Science Magazine

Today we have published the latest edition of our online science magazine: Regulatory Science Magazine. This edition contains the latest on research projects the MEB is involved in and interviews with Marieke De Bruin, professor of Drug Regulatory Science at Utrecht University and Jesper Kjær, head of the Data Analytics Centre of the Danish Medicines Authority.

Prof. Marieke De Bruin's mission is to contribute to public health by developing new tools that improve the regulatory system. To truly improve the regulatory system, collaboration between academic institutes and authorities is essential:

It forces all of us to leave our ivory towers. To see how things function in other areas. It’s also really necessary to understand the processes and the international dynamics, for instance at a European level. Working as a pharmacovigilance assessor at the MEB gave me both hands-on experience as well as insights and theoretical backgrounds on the functioning of the regulatory system. An open mindset, back and forth, can yield so much.

Before Marieke started her professorship in Utrecht in November 2020, she was professor of Regulatory Science in Copenhagen. This brings a Danish touch to the thirteenth edition of the Regulatory Science Magazine: The other lead article is in fact an interview with Jesper Kjær, head of the Data Analytics Centre (DAC) of the Danish Medicines Authority, Lægemiddelstyrelsen.

Getting more out of the data

A few years ago, the Danish agency set the course to work (even) more data-driven. The establishment of the DAC, for which Jesper was recruited as director, is the most tangible example of this. “By getting even more out of our data, we want to help increase the availability of safe and effective medicines even further,” says Jesper. In the article he discusses the use of Real World Data and the use of so-called CDISC Data in assessments, which can make the assessment faster and more accurate.

In addition, Regulatory Science Magazine 13 pays full attention to recent research in which the MEB is involved, such as projects by master students, the start of two new PhD students at the MEB and several partnerships.