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Publications

Comment on: “The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022”

Do efficacy results obtained from randomized controlled trials translate to effectiveness data from observational studies for relapsing-remitting multiple sclerosis?

Monoclonal antibody biosimilars for cancer treatment

A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model

Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance

Community Use of Repurposed Drugs Before and During COVID-19 Pandemic in the Netherlands: An Interrupted Time-Series Analysis

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

Eligibility for sotagliflozin in a real-world heart failure population based on the SOLOIST-WHF trial enrolment criteria: data from the Swedish heart failure registry

Eligibility for vericiguat in a real-world heart failure population according to trial, guideline and label criteria: Data from the Swedish Heart Failure Registry

Precision medicine in regulatory decision making: Biomarkers used for patient selection in European Public Assessment Reports from 2018 to 2020

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Press/media

Towards a more efficient use of registry-based real-world data in Europe: the More-EUROPA project

Peter Mol en Patrick Vrijlandt namens Nederland in het Europese CHMP

Oratie Peter Mol over kennisuitwisseling tussen wetenschap en medicijnautoriteit