prof. dr. P.G.M. (Peter) Mol

hoogleraar drug regulatory science

Faculteit Medische Wetenschappen/UMCG

Telefoon:

E-mail:

p.g.m.mol umcg.nl

ORCID Research Portal

Research interests

Peter Mol is professor of drug regulatory science at the University Medical Center Groningen. His research focus is on developing new tools to support regulatory decision-making and the exchange of knowledge between regulatory authorities, health care professionals and lay people. He is currently involved in projects around personalized medicine, new data sources (RWE), patient-centric ways to weigh drug benefit-risk; e.g., using Patient Relevant Outcomes, Quality of Life, and Patient Preference information, and on risk communication (Direct Healthcare Provider Communication). He is Principal Investigator of the HORIZON More-EUROPA project (More-Europa - Research (umcgresearch.org)).

He is also the Committee for Medicinal Products for Human Use (CHMP) member for the Dutch Medicines Evaluation Board. He was from 2012 to 2023 member (vice chair 2016-2022) of the European Medicines Agency (EMA) Scientific Advice Working Party. He has coordinated over 500 EMA and national scientific advice procedures for drug development programs for cardiometabolic, gynecology and hematology products. He was chair of the EMA Cross-Committee Task force on Registries (2016-2023).

Publicaties

Assessing Overall Survival Benefits in Advanced Cancers: The Role of External Comparator Cohort Studies with Real-World Data

Pignatti, F., El-Galaly, T. C., Kaiser, M., Porkka, K., Doeswijk, R., Mol, P., Rivera, D. R., Lerro, C. C., Rohr, U. P., Verpillat, P., Valachis, A., Trapani, D., Di Maio, M., Latino, N., Cordoba, R., Cherny, N., Koopman, M., Martins-Branco, D., Pentheroudakis, G. & Postmus, D., apr-2026, In: Clinical Pharmacology and Therapeutics. 119, 4, blz. 1080-1087 8 blz.

Onderzoeksoutput › › peer review

A target trial emulation of the CONFIRM study with an extension to subgroups: an example for relapsing-remitting multiple sclerosis

Verweij, S., Bijlsma, M. J., Rengerink, K. O., Hillert, J., Forsberg, L., Mouresan, E. F., Glaser, A., Fox, R. J., Hak, E. & Mol, P., 18-mrt-2026, (E-pub ahead of print) In: European Journal of Epidemiology.

Onderzoeksoutput › › peer review

Balancing benefit and risk in early Alzheimer's disease: the European Medicines Agency (EMA) assessment of lecanemab and donanemab

Guizzaro, L., Bałkowiec-Iskra, E., Haberkamp, M., Mol, P. G. M., Moreau, A., Mueller-Berghaus, J., Philadelphy, D., Balabanov, P., Garcia, J., Thirstrup, S. & Sepodes, B., 1-apr-2026, In: The Lancet Regional Health - Europe. 63, 8 blz., 101644.

Onderzoeksoutput › peer review

Magnitude of and outcome associated with inappropriate prescribing in heart failure with reduced ejection fraction: an analysis of 50 348 patients from the Swedish Heart Failure Registry

El-Hadidi, S., Lindberg, F., Benson, L., Uijl, A., Stolfo, D., Mol, P. G. M., Scorza, R., Cabrera, C. C., Abdin, A., Rosano, G. M. C. & Savarese, G., jan-2026, In: European Journal of Heart Failure. 28, 1, blz. 58-69 12 blz.

Onderzoeksoutput › › peer review

Repurposing Candidate Drugs to Prevent SARS-CoV-2: A PharmLines Test-Negative Case–Control Study

Lifelines Corona Research initiative, Zhou, G., Dael, N., Verweij, S., Balafas, S., Mubarik, S., Bos, J., Pasmooij, A. M. G., van Baarle, D., Mol, P. G. M., de Bock, G. H. & Hak, E., jun-2026, In: Pharmaceuticals. 19, 6, 16 blz., 861.

Onderzoeksoutput › › peer review

The European Medicines Agency review of belzutifan (Welireg) for the treatment of adult patients with von Hippel-Lindau disease-associated tumours

Baron, A., Broekman, E., van Gils, M., Poplavska, E., Mol, P., Saliete, I., Sepodes, B. & Pean, E., feb-2026, In: The Oncologist. 31, 2, 3 blz.

Onderzoeksoutput › peer review

Arrival of biosimilars in respiratory medicine: towards improved access to biologics for patients

van Boven, J. F. M., de Mora, F., Canonica, G. W., Mol, P. G. M. & Vulto, A. G., jul-2025, In: The Lancet Respiratory Medicine. 13, 7, blz. 574-576 3 blz.

Onderzoeksoutput: Comment/Letter to the editor › › peer review

Beta-blockers in patients with heart failure with reduced ejection fraction and concomitant chronic obstructive pulmonary disease: Cardiovascular and respiratory outcomes

Beer, B. N., Benson, L., Basile, C., Schrage, B., Becher, P. M., Blankenberg, S., Kirchhof, P., Szabó-Söderberg, B., Metra, M., Lindberg, A., Imbalzano, E., Rosano, G. M. C., Karlström, P., Mol, P. G. M., Scorza, R., Lund, L. H., Lindberg, F. & Savarese, G., dec-2025, In: European Journal of Heart Failure. 27, 12, blz. 2858-2868 11 blz.

Onderzoeksoutput › › peer review

Biomarkers for neurodegenerative diseases in regulatory decision-making by the European Medicines Agency

Hermans, A. M. M., Bakker, E., Starokozhko, V., den Otter, L., Elferink, A. J. A., Bradshaw, A., Guizzaro, L., Mol, P. G. M. & Pasmooij, A. M. G., 1-jan-2025, In: Alzheimer's and Dementia: Translational Research and Clinical Interventions. 11, 1, 13 blz., e70072.

Onderzoeksoutput › › peer review