Utrecht Centre for
Pharmaceutical Policy and Regulation
Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.
European collaboration on relative effectiveness assessments: What is needed to be successful?
Prescribing for acute childhood infections in developing and transitional countires, 1990-2009.
Patients’ perception of pharmacists’ role in the provision of pharmaceutical services at the KorleBu Teaching Hospital in Ghana.
Advancing the application of systems thinking in health: provider payment and service supply behaviour and incentives in the Ghana National Health Insurance Scheme – a systems approach.
Occurrence and clinical management of moderate-to-severe adverse events during drug-resistant tuberculosis treatment: a retrospective cohort study.
Adjusted Indirect Treatment Comparison of the Bioavailability of WHO-Prequalified First-Line Generic Antituberculosis Medicines
Piloting international production of rapid relative effectiveness assessments of pharmaceuticals.
Developing the hta core model for the online environment.
Standardized reporting for rapid relative effectiveness assessments of pharmaceuticals.
Compliance of Disease Awareness Campaigns in Printed Dutch Media with National and International Regulatory Guidelines.
Pediatric Drug Formulations: A Review of Challenges and Progress.
Incidence of adverse events among healthcare workers following H1N1 Mass immunization in Ghana: a prospective study.
Adverse events during treatment of drug-resistant tuberculosis: a comparison between patients with or without human immunodeficiency virus co-infection.
Regulatory review: How do agencies ensure the quality of decision making?
Outcomes of a Postexposure Prophylaxis Program at the Korle-Bu Teaching Hospital in Ghana: A Retrospective Cohort Study.
Impact of funding modalities on maternal and child health intervention coverage in Zambia.
The burden of adverse events during treatment of drug-resistant tuberculosis in Namibia.
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
Relative effectiveness assessment of pharmaceuticals: similarities and differences in 29 jurisdictions.
The patient & consumer voice and pharmaceutical industry sponsorship.
Medicines Regulatory Authority websites: Review of progress made since 2001.
Pharmaceutical sciences in 2020
Mapping the Safety Profile of Biologicals. A Disproportionality Analysis Using the WHO Adverse Drug Reaction Database, VigiBase.
Safety-Related Regulatory Actions for Orphan Drugs in the US and EU: A Cohort Study
Superior efficacy of new medicines?
Regulatory scientific advice in drug development: does company size make a difference?
The effect of advice to read the medicine/patient information leaflet among patients in Ghana: a crosssectional study.
Expediting patients' access to medicines by improving the predictability of drug development and the regulatoryapproval process.
Patient and Consumer Organisations at the European Medicines Agency: Financial disclosure and transparency
Direct Patient Reporting of Adverse Drug Reactions, A Fifteen-Country Survey & Literature review.
Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory.
Pharmacovigilance of Biopharmaceuticals, Challenges Remain
Pharmacovigilance of biosimilars from a regulatory point of view: Is there a need for specific approach?
Translation of rare disease research into orphan drug development: disease matters
Translation of rare disease research into orphan drug development: disease matters.
Psychotropic Drug Use: Between Healing and Enhancing the Mind.
No difference in between-country variability in use of newly approved orphan and non- orphan medicinal products - a pilot study
Therapeutic indications in oncology: Emerging features and regulatory dynamics.
Off-label use of medicines in children: can available evidence avoid useless paediatric trials?
Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs.
Utrecht Centre for
Policy and Regulation