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Regulatory Science Projects

Title: Regulatory Science Projects
Supervisor:  Peter GM Mol
Summary:  Regulatory science focuses on activities to remove regulatory hurdles for approval of medicinal products, while at the same time safeguarding that these medicinal products have an optimal benefit-risk balance throughout their life-cycle.
A current PhD project (Carla Jonker: CBG, Julius Centre Utrecht University) aims to identify the value of – and requirements for disease registries in new drug applications, but also to monitor drug risks post approval.
Other ongoing work focuses on informing healthcare professionals more effectively of drug risks that are discovered post approval.
Financing :  College ter Beoordeling van Geneesmiddelen
Start:  9/2007


The use of a multiple parameter response efficacy score to predict the effect of a drug on hard renal and cardiovascular
Diabetes Mellitus Treatment for Renal Insufficiency Consortium (DIAMETRIC) database 
System biology approach for discovery of biomarkers of renal disease progressioni in diabetes (SysKid)
PROVALID – prospective multinational cohort study in patients with type 2 diabetes treated in primary care
Vitamin-D deficiency as a risk marker for renal and CV complications in the general population
A novel approach of personalized medicine: considering multiple effects of a single drug
Optimal hard endpoints in clinical trials of renal disease progression
Albuminuria as surrogate endpoint in clinical trials
Individual therapy response to a sodium-glucose transport inhibitor
Involving patients in the assessment and evaluation of medication treatment
Groningen Initiative to Analyse Type-2 diabetes Treatment ( GIANTT )
The role of medication adherence in predicting treatment response and estimating cost-effectiveness of statin treatment
Pharmacogenetics and response to treatment of oral antidiabetics
Quality of prescribing: patient specific indicators that predict better outcomes in diabetes patients
Quality assessment of pharmacotherapy in patients with chronic kidney disease
Cost effectiveness of ACEi and ARBs on renal failure in diabetes patients
Drug information and risk communication in Africa
Regulatory Science Projects