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Drug News & Perspectives|February 16, 2010
European Medicines Agency support mechanisms fostering orphan drug developmentFlorence Butlen-Ducuing, Frida Rivière, Stiina Aarum, et al.Frontiers in Medicine|May 13, 2022
Biomarkers in Medicines Development-From Discovery to Regulatory Qualification and BeyondNatalie M Hendrikse, Jordi Llinares Garcia, Thorsten Vetter, et al.Nature Reviews. Drug Discovery|March 16, 2013
Animal models for metabolic, neuromuscular and ophthalmological rare diseasesGuillaume Vaquer, Frida Rivière, Maria Mavris, et al.Frontiers in Medicine|June 16, 2023
Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinatorsRobbe Saesen, Matilde Machado, Bianca Crifo, et al.Clinical Pharmacology and Therapeutics|February 9, 2022
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020Elisabeth Bakker, Natalie M Hendrikse, Falk Ehmann, et al.Drug Discovery Today|November 19, 2011
Determinants for successful marketing authorisation of orphan medicinal products in the EUMichelle Putzeist, Harald E Heemstra, Jordi Llinares Garcia, et al.Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|November 12, 2019
Unmet Medical Need: An Introduction to Definitions and Stakeholder PerceptionsRick A Vreman, Inkatuuli Heikkinen, Ad Schuurman, et al.The Oncologist|April 28, 2020
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell LymphomaIrene Papadouli, Jan Mueller-Berghaus, Claire Beuneu, et al.International Journal of Technology Assessment in Health Care|April 23, 2020
The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomesGiovanni Tafuri, Chantal Bélorgey, Carlo Favaretti, et al.International Journal of Technology Assessment in Health Care|August 23, 2021
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreementsHans-Georg Eichler, Roisin Adams, Einar Andreassen, et al.Pageof 2