Regulatory science provides the Medicines Evaluation Board (MEB) with up-to-date data, knowledge and expertise based on current scientific insights, for optimal evaluation and marketing authorisation of medicinal products and novel foods. This ensures an even better assessment of risks, efficacy and quality.
Research trajectories & programmes
On the MEB website you can find all the research trajectories and programmes the MEB supports.
The MEB’s Regulatory Science definition:
Regulatory Science is the science of developing and validating new standards and tools to evaluate andd assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making. Through analysis of regulatory frameworks itself and its effectiveness, however, Regulatory Science can also advance knowledge of these systems in general.
Thesis Highlight: Sonia Roldan Muñoz
I am a PhD student at the department of Clinical Pharmacy and Pharmacology of the University Medical Centre Groningen. My project is part of the PROMINENT program. PROMINENT is a four years programme composed of 16 international PhD students who will work on projects focusing on personalised medicine in diabetic chronic disease management. The projects within the PROMINENT program focus on all different aspects of personalised medicine from disease mechanisms and drug development to the regulation and good utilisation of medicines. The aim of the program is to contribute to the implementation and optimalisation of personalised medicine in all of these societal domains.
Since September 2018, I started my project under the supervision of Prof. Hans Hillege and dr. Peter Mol. Within my PhD project, we aim to integrate patient preferences into regulatory decisions. To do so, we will explore which factors influence the prescription of the different anti-diabetic drugs and the patients choices. We will also evaluate the current practices of medicines approval, compare the available efficacy and safety information among drug classes and apply a MCDA model to quantitatively weight the different drug effects. Ideally, we will be able to develop material that meets the patients’ needs and we will find a manner to feedback/inform? regulators with the outcomes.
- Read more about the student project of Anne Taams at the HSA in Singapore
- Read more about the student project of Timi Toiviainen of CORS meeting MEB
You can read more about the PRISM projects in the PRISM newsletter.
Niels Vlieland (UMCU): The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors; and #MedicijnNL over bewaarinstructies medicijnen
- Charlotte de Wolf: Regulating the regulators - monitoring immune mechanisms in targeted therapies.
Renske M.T. ten Ham, Utrecht Institute for Pharmaceutical Sciences (UIPS): Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe
- L.M. Henricks: Food-effect study on uracil and dihydrouracil plasma levels as marker for dihydropyrimidine dehydrogenase activity in human volunteers.
R.D.L.C. Bernabe 2018: Ethics in clinical trial regulation: https://www.tandfonline.com/doi/full/10.1080/03007995.2018.1528214
Yvonne Schuller 2018: Dose-finding studies among orphan drugs
Charles Laroche 2018: Finding synergies for 3Rs
Anna Radecka 2018: Enhancing pharmacovigilance capabilities in the eu regulatory network