Publicaties
Gekozen filters:
Gekozen filters:
Reimbursement of medicines in Belgium: role of evidence-based medicine Vrije Universiteit Brussel
The European Transparency Directive (TD) requires that pricing and reimbursement decisions must be taken in a transparent, objective and verifiable way with respect of strict timelines. The Belgian competent authority integrated on January 1st, 2002 Evidence-Based Medicine (EBM) principles in the reimbursement evaluation. The present work describes the procedures and investigates whether the introduction of the EBM principles indeed affects ...
Availability, accessibility and delivery to patients of the 28 orphan medicines approved by the European Medicine Agency for hereditary metabolic diseases in the MetabERN network KU Leuven
BACKGROUND: The European Medicine Agency granted marketing approval to 164 orphan medicinal products for rare diseases, among which 28 products intended for the treatment of hereditary metabolic diseases. Taking advantage of its privileged connection with 69 healthcare centres of excellence in this field, MetabERN, the European Reference Network for hereditary metabolic diseases, performed a survey asking health care providers from 18 European ...
The availability of six tracer medicines in private medicine outlets in Uganda Universiteit Antwerpen
Objectives Many low income countries struggle to provide safe and effective medicines due to poor public health care infrastructure, budgetary constraints, and lack of human resource capacity. Private sector pharmacies and drug shops are used by a majority of the population as an alternative to public pharmacies. This study looks at the availability of six essential medicines in private drug outlets across Uganda. Methods A standardised ...
Better medicines for neonates: Improving medicine development, testing, and prescribing KU Leuven
Pharmacotherapy is a powerful tool to improve the outcome of neonates. Unfortunately, the potential health impact of pharmacotherapy in neonates remains underexplored. This necessitates a structured approach to go beyond the current practice of trial and error, reflected in off-label prescription. The existing regulatory framework hereby provides a structure to reflect about aspects like pharmacokinetic models for dose selection and outcome ...
Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration Universiteit Antwerpen
The fifth multistakeholder Paediatric Strategy Forum focussed on epigenetic modifier therapies for children and adolescents with cancer. As most mutations in paediatric malignancies influence chromatin-associated proteins or transcription and paediatric cancers are driven by developmental gene expression programs, targeting epigenetic mechanisms is predicted to be a very important therapeutic approach in paediatric cancer. The Research to ...
Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration Universiteit Antwerpen
The seventh multi-stakeholder Paediatric Strategy Forum focused on chimeric antigen receptor (CAR) T-cells for children and adolescents with cancer. The development of CAR T-cells for patients with haematological malignancies, especially B-cell precursor acute lymphoblastic leukaemia (BCP-ALL), has been spectacular. However, currently, there are scientific, clinical and logistical challenges for use of CAR T-cells in BCP-ALL and other paediatric ...
ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients Universiteit Antwerpen
The third multistakeholder Paediatric Strategy Forum organised by ACCELERATE and the European Medicines Agency focused on immune checkpoint inhibitors for use in combination therapy in children and adolescents. As immune checkpoint inhibitors, both as monotherapy and in combinations have shown impressive success in some adult malignancies and early phase trials in children of single agent checkpoint inhibitors have now been completed, it seemed ...