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Presentations

Latest Presentations

Post thumbnail Specificities & Challenges in Development Strategy for ATMPs in the EU
Post thumbnail Specificities & Challenges in Development Strategy for ATMPs in the EU 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…

Post thumbnail A Nonclinical Perspective on the Cell, Gene & Immunotherapy Need-to-Know Characteristics
Post thumbnail A Nonclinical Perspective on the Cell, Gene & Immunotherapy Need-to-Know Characteristics 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…

Post thumbnail Overview of EU Regulatory Landscape for Regenerative Medicines
Post thumbnail Overview of EU Regulatory Landscape for Regenerative Medicines presentation
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…

Post thumbnail Understanding the Implications of the New IVDR for Companion Diagnostics (CDx)
Post thumbnail Understanding the Implications of the New IVDR for Companion Diagnostics (CDx) 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…

Post thumbnail Impact of the New Medical Device Regulation on Clinical Evaluations and Investigations
Post thumbnail Impact of the New Medical Device Regulation on Clinical Evaluations and Investigations presentation
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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