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

professor of drug regulatory science

Faculty of Medical Sciences

Telephone:

E-mail:

p.g.m.mol umcg.nl

ORCID Research Portal

Publications

Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making

Bakker, E. , Plueschke, K. , Jonker, C. J. , Kurz, X. , Starokozhko, V. & Mol, P. G. M. , Jan-2023 , In: Clinical Pharmacology & Therapeutics. 113 , 1 , p. 135-151 17 p.

Research output: Contribution to journal › Article › Academic › peer-review

Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports

Starokozhko, V. , Tarrahi, F. , Vrijlandt, P. J. W. S. & Mol, P. G. M. , Apr-2023 , In: Clinical Pharmacology and Therapeutics. 113 , 4 , p. 859-866 8 p.

Research output: Contribution to journal › Article › Academic › peer-review

Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe

the STARS consortium , Kallio, M. J. , Starokozhko, V. , Agricola, E. , Burggraf, M. , Heß, A. , Ballensiefen, W. , Löbker, W. , Nuevo, Y. , Pasmooij, A. M. G. & Mol, P. G. M. , Feb-2023 , In: Clinical Pharmacology and Therapeutics. 113 , 2 , p. 349-359 11 p.

Research output: Contribution to journal › Article › Academic › peer-review

Aandacht voor vrouwen in geneesmiddelenonderzoek

de Vries, S. , Vrijlandt, P. , Havinga, I. K. & Mol, P. G. M. , 1-Apr-2022 , In: PiL Praktijkgerichte nascholing over farmacotherapie in de eerste lijn. 12 , 1 , p. 51-55 5 p.

Research output: Contribution to journal › Article › Professional

Attention for sex in COVID-19 trials: a review of regulatory dossiers

de Vries, S. T. , Starokozhko, V. , Schellens, I. M. M. , Wijnans, L. , Enzmann, H. , Cavaleri, M. & Mol, P. G. M. , 2022 , In: BMJ Global Health. 7 , 3 , 9 p. , 008173.

Research output: Contribution to journal › Review article › peer-review

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020

Bakker, E. , Hendrikse, N. M. , Ehmann, F. , Van der Meer, D. S. , Llinares Garcia, J. , Vetter, T. , Starokozhko, V. & Mol, P. G. M. , Jul-2022 , In: Clinical Pharmacology & Therapeutics. 112 , 1 , p. 69-80 12 p.

Research output: Contribution to journal › Article › Academic › peer-review

Drug Regulatory Science: Collaborate to improve drug development and evaluation

Mol, P. G. M. , 2022 , University of Groningen Press . 37 p. (Inaugural Lectures)

Research output: Book/Report › Inaugural speech

Editorial: Insights in Regulatory Science 2021

Sepodes, B. & Mol, P. , 20-Sept-2022 , In: Frontiers in Medicine. 9 , 3 p. , 1033558.

Research output: Contribution to journal › Editorial › Academic › peer-review

Factors Influencing Preferences and Responses Towards Drug Safety Communications: A Conjoint Experiment Among Hospital-Based Healthcare Professionals in the Netherlands

de Vries, E. , Bakker, E. , Monster, T. B. M. , Denig, P. & Mol, P. G. M. , Nov-2022 , In: Drug Safety. 45 , p. 1369-1380 12 p.

Research output: Contribution to journal › Article › Academic › peer-review

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach

de Vries, E. , Bakker, E. , Francisca, R. D. C. , Croonen, S. , Denig, P. & Mol, P. G. M. , 2022 , In: Drug Safety. 45 , 4 , p. 369–378 10 p.

Research output: Contribution to journal › Article › Academic › peer-review

All (122) publications

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