My motivation for this PhD project arises from a broad experience within pharmacovigilance. I started my career in the pharmaceutical industry where you work by standards set by the Agency. My curiosity towards why and how these rules and regulations were developed, were the main reason to accept an offer from the Danish Medicines Agency. With this project, I see an opportunity to further use my broad experience to contribute to the regulatory field and hopefully to patient safety.
Education and experience:
I am a trained pharmacist with a broad and extensive (13 years) experience within pharmacovigilance, including six years in the pharmaceutical industry and eight years at a regulatory authority. In addition, I am a certified Project Manager and hold a BA in Philosophy. As a senior assessor, I am responsible for training, development and maintenance of scientific and regulatory competences in the Section of Pharmacovigilance at the Danish Medicines Agency.
Title PhD project:
Optimizing the tools for drug regulation, the added value of Periodic Safety Update Reporting in Pharmacovigilance.
PhD project description:
The Periodic Safety Update Report (PSUR) is one regulatory instrument among several others with the primary aim of preventing and minimising harm from adverse drug reactions. Does the PSUR, however, contribute to patients’ safety? The evidence from current research is conflicting and outdated. As we demand that medicines are effective, this should also be the case for the system overseeing medicines.
The regulatory framework for medicines in the EU is evolving constantly. The system changes in order to adapt to scientific developments and increased expectations. With these changes comes also an increased risk of overlap and redundancy between procedures, pertaining to the data they evaluate and the objectives they examine. These changes demand a continuous reflection on whether or not the regulatory system is achieving its intended goals. The primary objective of this project is to evaluate the PSUR impact on patients’ safety in relation to other pharmacovigilance activities.
Teammembers and other people involved:
Dr. Helga Gardarsdottir, Prof. Bert Leufkens, Prof. Marieke de Bruin.
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