Centre for Pharmaceutical Policy and Regulation

2024

P38 Strengthening primary health care through a stronger emphasis on patient and community centered medicines and pharmaceutical services

Leopold, C., Vogler, S., Suleman, F. & Wirtz, V. J., 12 Apr 2024, In: Journal of Pharmaceutical Policy and Practice. 17, 1, 2331920.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

2023

Evolving Pico Characteristics in the Early Oncology Treatment Lifecycle: Differences From Trials to Treatment Guidelines

Hogervorst, M., Vreman, R. A., Mantel-Teeuwisse, A. K., Goettsch, W. G. & Kesselheim, A. S., Jun 2023, In: Value in Health. 26, 6, p. S218-S219 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Systematic review of externally controlled (EC) trials, data used in them, and their role in regulatory decision-making

Eskola, S. M., Jokinen, S., Bloem, L. T., Brouwer, E., Brown, D. A., Camarero, J., De Bruin, M. L. L., Gardarsdottir, H. & Hakkarainen, K. M., Oct 2023, In: Pharmacoepidemiology and Drug Safety. 32, supplement 1, p. 260-261 2 p., 260.

Research output: Contribution to journal › Meeting Abstract › Other research output

2022

Applicability of Appraisal Tools of Real-World Evidence in Health Technology Assessment: A Literature Review and Content Analysis

Jiu, L., Hartog, M. K., Wang, J., Vreman, R. A., Mantel-Teeuwisse, A. K. & Goettsch, W. G., Dec 2022, In: Value in Health. 25, 12, p. S389-S389 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Building Bridges Between Regulation, Health Technology Assessment and Clinical Guideline Development

Hogervorst, M., Mollebaek, M., Vreman, R. A., Wang, J., Mantel-Teeuwisse, A. K. & Goettsch, W., Dec 2022, In: Value in Health. 25, 12, p. S233-S234 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Evaluating Prediction Model Calibration at the Moderate-strong Level Using Patient Subgroups Identified with Clustering Analysis

Wang, J., Jiu, L., Tapia-Galisteo, J., Somolinos-Somon, F. J., Garcia-Saez, G., Hernando, M. E. & Goettsch, W., Dec 2022, In: Value in Health. 25, 12, p. S367-S367 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Payment and Reimbursement Models for Innovative High-priced Hospital Drugs in the Netherlands: A Survey of Stakeholder's Attitudes and Experiences

Callenbach, M. H. E., Vreman, R. A., Goettsch, W. G. & Mantel-Teeuwisse, A. K., Dec 2022, In: Value in Health. 25, 12, p. S261-S261 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

The Methodological Quality of Retrospective Observational Studies to Evaluate Glucose Monitoring Systems in Diabetes Patients: A Systematic Review

Jiu, L., Junfeng, W., Vreman, R. A., Mantel-Teeuwisse, A. K. & Goettsch, W., Jan 2022, In: Value in Health. 25, 1, p. S209-S209 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

To Merge Randomized Controlled Trials and Real-world Evidence with Bayesian Network Meta-regression: A Case Study in Patients with Myelodysplastic Syndromes

Jiu, L., Wang, J., Mantel-Teeuwisse, A. K. & Goettsch, W. G., Dec 2022, In: Value in Health. 25, 12, p. S354-S354 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Uncertainties Around Tumour Agnostic Therapies in Europe: Barriers and Facilitators of Patient Access

Hogervorst, M., Goettsch, W., Mantel-Teeuwisse, A. K., Bloem, L. & Vreman, R. A., Dec 2022, In: Value in Health. 25, 12, p. S266-S266 1 p.

Research output: Contribution to journal › Meeting Abstract › Other research output

Uncertainty Regarding the Long-term Effectiveness of New Therapies in Health Technology Assessment

Versteeg, J. W., Hogervorst, M., Mantel-Teeuwisse, A. K., Goettsch, W. G. & Vreman, R. A., Dec 2022, In: Value in Health. 25, 12, p. S305-S305 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

2019

Adherence to direct oral anticoagulants in patients with non-valvular atrial fibrillation cross-national comparison in six european countries

Sabaté Gallego, M., Ibáñez Mora, L., Vidal Guitart, X., Ballarin Alins, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Martin Merino, E., Montero, D., León-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjaer, M., Andersen, M., De Briun, M., Groenwold, R. & Van Den Ham, R. & 3 others, Souverein, P., Klungel, O. & Gardarsdottir, H., 1 Jun 2019, In: European Journal of Clinical Pharmacology. 75, p. 27-28 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Incidence of direct oral anticoagulation use for non valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-national drug utilization study

Ibanez, L., Sabaté, M., Vidal, X., Ballarín, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Merino, E. M., Montero, D., Leon-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjaer, M., Andersen, M., De Bruin, M. L., Groenwold, R. & Van Den Ham, R. & 3 others, Souverein, P., Klungel, O. & Gardarsdottir, H., 1 Aug 2019, In: Pharmacoepidemiology and Drug Safety. 28, S2, p. 397 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

PBI75 Review of Economic Evaluations for gene therapies: are we ready for the future?

ten Ham, R., Leufkens, H. G., Klungel, O. H. & Fredrix, G., Nov 2019, In: Value in Health. 22, supplement 3, 2 p., S431.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

Prescribers' compliance with SmPC recommendations for dabigatran, rivaroxaban, and Apixaban: A European comparative drug utilization study

Rottenkolber, M., Schmiedl, S., Ibanez, L., Sabaté, M., Ballarín, E., Vidal, X., Leon-Munoz, L. M., Huerta, C., Martin Merino, E., Montero, D., Gasse, C., Andersen, M., Aakjær, M., De Bruin, M. L., Gerlach, R., Tauscher, M., Souverein, P. C., Van Den Ham, R., Klungel, O. & Gardarsdottir, H., Aug 2019, In: Pharmacoepidemiology and Drug Safety. 28, S2, p. 148-149 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

Risk of major bleeding associated with the use of direct oral anticoagulants compared to vitamin K antagonists in patients with atrial fibrillation: A European multicountry population-based cohort study

Souverein, P. C., Van Den Ham, H. A., Huerta, C., Merino, E. M., Montero, D., León-Muñoz, L. M., Schmiedl, S., Rottenkolber, M., Andersen, M., Aakjær, M., De Bruin, M. L., Klungel, O. H. & Gardarsdottir, H., 1 Aug 2019, In: Pharmacoepidemiology and Drug Safety. 28, S2, p. 553-553 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Risk of major bleeding associated with the use of individual direct oral anticoagulants compared to vitamin K antagonists in patients with non-valvular atrial fibrillation: A metaanalysis of results from multiple population based cohort studies using a common protocol in Europe and Canada

van den Ham, H., Souverein, P., Klungel, O., Platt, R., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Merino, E. M., Leon-Munoz, L., Montero, D., Andersen, M., Aakjaer, M., Bruin, M. L. D. & Gardarsdottir, H., Aug 2019, In: Pharmacoepidemiology and Drug Safety. 28, S2

Research output: Contribution to journal › Meeting Abstract › Academic

Risk of major bleeding associated with the use of individual direct oral anticoagulants compared to vitamin K antagonists in patients with non-valvular atrial fibrillation: A metaanalysis of results from multiple population based cohort studies using a common protocol in Europe and Canada

Van Den Ham, H., Souverein, P., Klungel, O., Platt, R., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Merino, E. M., León-Muñoz, L., Montero, D., Andersen, M., Aakjær, M., De Bruin, M. & Gardarsdottir, H., 1 Aug 2019, In: Pharmacoepidemiology and Drug Safety. 28, S2, p. 410-411 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

TNF-alpha inhibitor treatment patterns in patients with rheumatic diseases and those with inflammatory bowel disease

Meijboom, R. W., Gardarsdottir, H., Becker, M. L., Egberts, T. C. G., Leufkens, H. G. M. & Giezen, T. J., 20 Aug 2019, In: Pharmacoepidemiology and Drug Safety. 28, S2, p. 265-265 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

2018

Concurrent use of DOACs and pharmacodynamic interacting drugs is associated with an increased risk of major bleeding compared with patients using DOACs alone: Nested case-control study in UK CPRD

Zhang, Y., De Boer, A., Gardarsdottir, H., Van Den Ham, H. A., Maitland-Van Der Zee, A. H. & Souverein, P. C., 1 Aug 2018, In: Pharmacoepidemiology and Drug Safety. 27, p. 465-466 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

File

Exploring the association between monoclonal antibodies and depression and suicidal ideation and behavior: A vigibase study

Minnema, L., Giezen, T., Souverein, P., Egberts, T., Leufkens, B. & Gardarsdottir, H., 1 Nov 2018, In: Drug Safety. 41, 11, p. 1197-1198 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Exploring the association between monoclonal antibodies and depression and suicidal ideation and behaviour: A VigiBase study

Minnema, L. A., Giezen, T. J., Souverein, P. C., Egberts, T. C. G., Leufkens, H. G. M. & Gardarsdottir, H., 1 Aug 2018, In: Pharmacoepidemiology and Drug Safety. 27, p. 50 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Regulatory challenges in the design of non-inferiority trials: Evaluating scientific advice letters from the European Medicines Agency (EMA)

Althunian, T., De Boer, A., Mantel-Teeuwisse, A. K., Groenwold, R. H. H., Gispen-De Wied, C. C., Leufkens, H. G. M., Elferink, A. & Klungel, O. H., 1 Aug 2018, In: Pharmacoepidemiology and Drug Safety. 27, S2, p. 149 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

File

Using social media to collect patient perspectives on quality of life: A feasibility study

Makady, A., Kalf, R., Ryll, B., Spurrier, G., De Boer, A., Hillege, H., Klungel, O. & Goettsch, W., 1 Aug 2018, In: Pharmacoepidemiology and Drug Safety. 27, p. 56 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

File

2017

Burden of out-of-pocket spending among high-deductible health plan members with metastatic breast cancer

Leopold, C., Wagner, A. K., Zhang, F., Lu, C., Earle, C. C., Nekhlyudov, L., Ross-Degnan, D. & Wharam, J. F., 30 May 2017, In: Journal of Clinical Oncology. 35, 15 suppl., 1029.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

How to measure the impact of pharmacovigilance activities on public health?

Gardarsdottir, H., Kant, A., De Bruin, M. L., Hallgren, C. E., Pan, G. D. & Way, D., 1 Aug 2017, In: Pharmacoepidemiology and Drug Safety. 26, p. 31 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Noacs replace VKA as preferred oral anticoagulant among new patients

Van Den Heuvel, J. M., Hövels, A. M., Büller, H. R., Mantel-Teeuwisse, A. K., De Boer, A. & Maitland-Van Der Zee, A. H., 1 Aug 2017, In: Pharmacoepidemiology and Drug Safety. 26, p. 565-566 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

File

Post-marketing label changes in dosing information of biopharmaceuticals-different from small molecules?

Minnema, L. A., Giezen, T. J., Gardarsdottir, H., Egberts, T. C. G., Leufkens, H. G. M. & Mantel-Teeuwisse, A. K., 1 Aug 2017, In: Pharmacoepidemiology and Drug Safety. 26, p. 606-607 2 p.

Research output: Contribution to journal › Meeting Abstract › Academic

Risk factors associated with post-marketing changes in specific obligations of conditionally authorised products in the EU

Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H. & Hoekman, J., 1 Aug 2017, In: Pharmacoepidemiology and Drug Safety. 26, p. 605 1 p.

Research output: Contribution to journal › Meeting Abstract › Other research output

Understanding the Treatment Choice Between Insulin Glargine, Detemir and Human Insulin: Characteristics of Patients with Type 2 Diabetes Starting Insulin in Five European Countries

Bazelier, M., Ekstrom, N., Karlstad, O., Vestergaard, P., Haukka, J., de Vries, F., Furu, K., Andersen, M. & De Bruin, M., Aug 2017, In: Pharmacoepidemiology and Drug Safety. 26, p. 124-124 1 p.

Research output: Contribution to journal › Meeting Abstract › Academic

2016

Disparities in all-cause mortality among younger commercially insured women with metastatic breast cancer

Leopold, C., Zhang, F., Wagner, A. K., Lu, C., Earle, C. C., Ross-Degnan, D. & Wharam, J. F., 20 May 2016, In: Journal of Clinical Oncology. 34, 15 suppl, 18069.

Research output: Contribution to journal › Meeting Abstract › Academic

Open Access

Centre for Pharmaceutical Policy and Regulation

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