Evidence generation on benefits and risks of medicines and its impact on regulatory and downstream decision-making

Abstract

Evidence generation on benefits and risks of medicines and its impact on regulatory and downstream decision-making Lourens Theo BloemThe studies presented in this thesis have been conducted under the umbrella of the Regulatory Science collaboration between the Dutch Medicines Evaluation Board (CBG-MEB) and the Utrecht Institute for Pharmaceutical Sciences (UIPS). The CBG-MEB is dedicated to ensuring that licensed medicinal products during their whole lifecycle have a positive benefit-risk. This role requires intensive collaboration with academic and clinical partners in order to develop new assessment and decision-making methods, to engage with the clinic and to strengthen regulatory science. This PhD thesis aims to go beyond its scientific merits as such by delivering science, learning and insight to promote public health.