Violeta V. Beninska-Stoyanova

Amsterdam, NH, Netherlands

Last Updated: 09/26/2026

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Found 37 publications

Paediatric medicines development for Duchenne muscular dystrophy: An EU regulatory perspective.

Paediatric medicines development for Duchenne muscular dystrophy: An EU regulatory perspective.

Journal: Journal of neuromuscular diseases

Published: November 18, 2025

Tracing the path of non-industry-driven medicine development for rare diseases through regulatory interactions at the European Medicines Agency.

Tracing the path of non-industry-driven medicine development for rare diseases through regulatory interactions at the European Medicines Agency.

Journal: Drug discovery today

Published: November 02, 2025

Tracing the path of non-industry-driven medicine development for rare diseases through regulatory interactions at the European Medicines Agency.

Tracing the path of non-industry-driven medicine development for rare diseases through regulatory interactions at the European Medicines Agency.

Journal: Drug discovery today

Published: November 02, 2025

Non-oncologic orphan drug approvals across the world: Types of evidence required and time to approval.

Non-oncologic orphan drug approvals across the world: Types of evidence required and time to approval.

Journal: Drug discovery today

Published: August 14, 2025

Addressing global regulatory challenges in rare disease drug development.

Addressing global regulatory challenges in rare disease drug development.

Journal: Drug discovery today

Published: June 13, 2025

Editorial: The changing focus of regulatory frameworks around the globe and the opportunities for harmonization.

Editorial: The changing focus of regulatory frameworks around the globe and the opportunities for harmonization.

Journal: Frontiers in medicine

Published: June 11, 2025

Drug Repurposing in Pancreatic Cancer: A Multi-Stakeholder Perspective to Improve Treatment Options for Pancreatic Cancer Patients.

Drug Repurposing in Pancreatic Cancer: A Multi-Stakeholder Perspective to Improve Treatment Options for Pancreatic Cancer Patients.

Journal: Cancer management and research

Published: August 29, 2024

Navigating the orphan medicinal product designation: Evidence requirements for gene therapies in Europe.

Navigating the orphan medicinal product designation: Evidence requirements for gene therapies in Europe.

Journal: Molecular therapy : the journal of the American Society of Gene Therapy

Published: April 30, 2024

Feasibility of disease terminology systems for mapping orphan conditions and therapeutic indications of designated orphan medicines in the European Union.

Feasibility of disease terminology systems for mapping orphan conditions and therapeutic indications of designated orphan medicines in the European Union.

Journal: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

Published: April 30, 2024

Inherited retinal dystrophies and orphan designations in the European Union.

Inherited retinal dystrophies and orphan designations in the European Union.

Journal: European journal of ophthalmology

Published: March 19, 2024

Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.

Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.

Journal: Clinical pharmacology and therapeutics

Published: January 11, 2024

Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.

Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.

Journal: Gene therapy

Published: December 01, 2023

Showing 1-12 of 37

Last Updated: 09/26/2026