dr. A.B. (Miriam) Vleuten

dr. A.B. (Miriam) Vleuten

Full Professor
dr. A.B. (Miriam) Vleuten
  • Department of Biostatistics and Research Support

Research Programs

Child Health



Miriam Sturkenboom is head of the Department of Datascience and Biostatistics in the Julius Center at University Medical Center Utrecht in the Netherlands. She has a PhD from the Faculty of Mathematics and Physics in Groningen (cum laude), a pharmacy degree from the same University and a Master in Epidemiology from the Harvard School of Public Health. She is past president of the International Society for Pharmacoepidemiology. She served as expert to EMA, FDA, WHO and many other organizations. She was professor of Observational Data Anlysis at the department of Medical Informatics at Erasmus MC till 2017, and currently is professor of Real World Evidence at the University Medical Center Utrecht

Her research interests focus on transforming real world data into real world evidence on drug use, effectiveness and safety in vulnerable populations (children, pregnancy and elderly). Her research focuses on the creation of international ecosystems that allow for big data mining, pooling and analysis to learn about the use and effects of drugs after marketing. These infrastructures have been tested and used as prototypes in many distributed networks in projects funded by the European Commission, the Innovative Medicines Initiative, the European Medicines Agency, ECDC, and also privately funded projects that she coordinate(d/s). She was coordinator of the IMI funded ADVANCE public private collaboration, aiming to establish a tested system for the monitoring of benefits and risks of vaccines. She is coordinator of the IMI-funded ConcepTION project, building an ecosystem to assess drugs safety in pregnancy and lactation. She was member of the WHO Global Advisory Committee for Vaccine Safety. She is president of the Vaccine Monitoring Collaboration for Europe (  and coordinates several studies on COVID019 vaccine safety monitoring for the European Medicines Agency

Side Activities

Freelancer, Coaching persoonlijke groei (Zijnsorientatie). 1 June 2017-now

Freelancer, Consultant Task Force for Global Health USA for SPEAC project (CEPI). 1 June 2017-now

Freelancer, Consultant PHARMO Institute study. 1 June 2017-now

Research Output (114)

Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries

Watson Gabriella, Dodd Caitlin, Munoz Flor M, Eckert Linda O, Jones Christine E, Buttery Jim P, Yildirim Inci B, Kachikis Alisa, Heath Paul T, Schlaudecker Elizabeth P, Bond Nanette H, Santarcangelo Patricia L, Wilcox Christopher R, Bellamy Karen, Elmontser Mohnd, Sienas Laura, Simon Rebecca, Khalil Asma, Townsend Rosemary, Sturkenboom Miriam, Black Steve 28 Sep 2021, In: The Pediatric infectious disease journal. 40 , p. 1127-1134 8 p.

Use and performance of Brighton Collaboration case definitions in low-middle income settings

Huang Wan-Ting, Yang TienYu Owen, Law Barbara, Black Steve, Sturkenboom Miriam, Chen Robert Aug 2021, In: Pharmacoepidemiology and Drug Safety. 30 , p. 381-382

The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety

Black Steven B, Law Barbara, Chen Robert T, Dekker Cornelia L, Sturkenboom Miriam, Huang Wan-Ting, Gurwith Marc, Poland Greg 6 May 2021, In: Vaccine. 39 , p. 2712-2718 7 p.

The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness

Cocoros Noelle M, Arlett Peter, Dreyer Nancy A, Ishiguro Chieko, Iyasu Solomon, Sturkenboom Miriam, Zhou Wei, Toh Sengwee May 2021, In: Clinical Pharmacology and Therapeutics. 109 , p. 1189-1196 8 p.

Challenges Associated with the Safety Signal Detection Process for Medical Devices

Pane Josep, Verhamme Katia M.C., Villegas Dorian, Gamez Laura, Rebollo Irene, Sturkenboom Miriam C.J.M. 24 Feb 2021, In: Medical devices (Auckland, N.Z.). 2021 , p. 43-57 15 p.

Incidence Rates of Autoimmune Diseases in European Healthcare Databases:A Contribution of the ADVANCE Project

Willame Corinne, Dodd Caitlin, van der Aa Lieke, Picelli Gino, Emborg Hanne-Dorthe, Kahlert Johnny, Gini Rosa, Huerta Consuelo, Martín-Merino Elisa, McGee Chris, de Lusignan Simon, Roberto Giuseppe, Villa Marco, Weibel Daniel, Titievsky Lina, Sturkenboom Miriam C J M 19 Jan 2021, In: Drug Safety. 44 , p. 383-395 13 p.

How to ensure we can track and trace global use of COVID-19 vaccines? Comment

Vander Stichele Robert H, Hay Christian, Fladvad Malin, Sturkenboom Miriam C J M, Chen Robert T 8 Jan 2021, In: Vaccine. 39 , p. 176-179 4 p.

Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU:An Explorative Study on Relevant Factors

Hoeve Christina E, de Vries Esther, Mol Peter G M, Sturkenboom Miriam C J M, Straus Sabine M J M Jan 2021, In: Drug Safety. 44 , p. 73-82 10 p.

Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda:A qualitative study approach

Kajungu Dan, Muhoozi Michael, Stark James, Weibel Daniel, Sturkenboom Miriam C J M Dec 2020, In: PLoS ONE. 15 , p. 1-17

All research output

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