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New Regulatory Flexibility in the EU: The Value of Platform Technologies for Public Health
Session Chair(s)
Michela Gabaldo, PHARMD, MSC
VP ATMP Global Regulatory Affairs, Evotec, Italy
This session aims to discuss the need to converge on the definitions of Platform Technology in Drug Development in order to foster the translation of potentially life-changing drugs that leverage from prior knowhow. Real case studies on mRNA medicinal product and on ex-vivo gene therapies will be presented, along with the Regulatory perspective on this hot topic.
Learning Objective : Participants will identify elements of the new legal regulatory framework on platform technologies, proposed by the EC. They will recall new options and discuss potential challenges from patients, regulators, academia, and developer perspectives.
Speaker(s)
Maren von Fritschen, PHARMD
Drug Development and Regulatory Affairs - MSC Course, University of Applied Sciences, Germany
New Regulatory Flexibility in the EU: Legal Options for Platform Approaches in the EC Proposal
Maria Ester Bernardo
Group Leader/Physician Scientist, IRCCS Ospedale SAN RAFFAELE, Italy
An Innovative Platform Approach for the CMC, Pre-clinical, and Clinical Development of Ex-Vivo Gene Therapy for Lysosomal Storage Disorders with Skeletal Involvement
Falk Ehmann, MD, PHD, MS
Head of Innovation and Development Accelerator, Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
EMA's Expectations on Platform Technology Elements: Efficient Regulators' Assessment Based on Platform Technology Elements From Prior Knowledge
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