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View article: Optimizing Patient Registries for Regulatory Decision Making ‐ Key Learnings From an <scp>HMA</scp>/<scp>EMA</scp> Multistakeholder Workshop
Optimizing Patient Registries for Regulatory Decision Making ‐ Key Learnings From an <span>HMA</span>/<span>EMA</span> Multistakeholder Workshop Open
The Joint Heads of Medicines Agencies and European Medicines Agency's (HMA/EMA) big data initiative paves the way for better integration of real‐world data, including data from patient registries, into regulatory decisions on medicines. Th…
View article: Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency Open
Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the des…
View article: Identifying and overcoming challenges in the EMA’s qualification of novel methodologies: a two-year review
Identifying and overcoming challenges in the EMA’s qualification of novel methodologies: a two-year review Open
The EMA Qualification of Novel Methodologies procedure qualifies methods, technologies and methodologies within a well-defined context of use in a pharma R&D context based on the evaluation of the presented scientific rationale and sub…
View article: Patient‐reported, observer‐reported and performance outcomes in qualification procedures at the European Medicines Agency 2013–2018
Patient‐reported, observer‐reported and performance outcomes in qualification procedures at the European Medicines Agency 2013–2018 Open
Aims To describe characteristics of applicant, tool, outcomes, regulatory responses and general learnings from European Medicines Agency (EMA) Qualification Procedures on patient‐reported outcomes (PROs), observer‐reported outcomes (ObsROs…
View article: Reverse Engineering of Digital Measures: Inviting Patients to the Conversation
Reverse Engineering of Digital Measures: Inviting Patients to the Conversation Open
Background: Digital measures offer an unparalleled opportunity to create a more holistic picture of how people who are patients behave in their real-world environments, thereby establishing a better connection between patients, caregivers,…
View article: Evolving regulatory perspectives on digital health technologies for medicinal product development
Evolving regulatory perspectives on digital health technologies for medicinal product development Open
View article: EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age Open
As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice p…
View article: Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond
Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond Open
Biomarkers are important tools in medicines development and clinical practice. Besides their use in clinical trials, such as for enrichment of patients, monitoring safety or response to treatment, biomarkers are a cornerstone of precision …
View article: Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020 Open
Regulatory qualification of biomarkers facilitates their harmonized use across drug developers, enabling more personalized medicine. This study reviews various aspects of the European Medicines Agency’s (EMA’s) biomarker qualification proc…
View article: Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting
Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting Open
Aim: This study aimed to identify from different stakeholders the benefits and obstacles of implementing precision medicine in diabetic kidney disease (DKD) and to build consensus about a way forward in order to treat, prevent, or even rev…
View article: Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators
Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators Open
View article: Marketing authorisation of orphan medicines in Europe from 2000 to 2013
Marketing authorisation of orphan medicines in Europe from 2000 to 2013 Open
An analysis was performed on a data set of 157 orphan designated medicines with an outcome for marketing authorisation application (MAA) between 2000 and 2013. The intention was to understand the factors associated with marketing authorisa…
View article: Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference
Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference Open