Latest Presentations
presentation
Cell & Gene Therapy
Specificities & Challenges in Development Strategy for ATMPs in the EU
Florence Bine-Sheck, Senior Medical Director at VCLS, shares her insights on the clinical and regulatory aspects of ATMP development in…
presentation
Cell & Gene Therapy
A Nonclinical Perspective on the Cell, Gene & Immunotherapy Need-to-Know Characteristics
After a brief look at the current European Guidelines for Advanced Therapy Medicinal Products (ATMPs), this presentation will go through…
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EMA
Overview of EU Regulatory Landscape for Regenerative Medicines
Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing…
presentation
Medical Device
Understanding the Implications of the New IVDR for Companion Diagnostics (CDx)
IVD Regulation is evolving, with direct impacts on CDx development. The purpose of this presentation will be to explore special…
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Medical Device
Impact of the New Medical Device Regulation on Clinical Evaluations and Investigations
Developing and marketing a medical device in Europe has to follow the European law covered today by the Medical Device…
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