This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some key points like safety and performance aspects for medical device software, Clinical Validation for Medical Device Software and Regulatory...

What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective

  • Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements;...

The launch of a product is one of the most critical moments in its life-cycle. The product trajectory is firm within the first six months for 85% of pharmaceutical launch. Understand the end goal and product-specific requirements. Rely on science and experience as it is a...

Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening....

The current regulatory framework for Clinical Trials in the EU is the Clinical Trial Directive 2001/20/EC (CTD) which entered into force in 2004. The CTD objective was to provide reliability and robustness of CT while ensuring respect of the rights, safety, dignity and well-...

Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing costs, incremental benefit claims that extend over an extended time frame, restriction to centres of...

Florence Bine-Sheck, Senior Medical Director at VCLS, shares her insights on the clinical and regulatory aspects of ATMP development in Europe.

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After a brief look at the current European Guidelines for Advanced Therapy Medicinal Products (ATMPs), this presentation will go through the nonclinical development plan for ATMPs and how to ease its translation to the clinical setting, focusing on the nonclinical...

Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing or regenerating cells, tissues or organs in Human. In Europe, they are governed by the ATMP regulation, which entered...

IVD Regulation is evolving, with direct impacts on CDx development. The purpose of this presentation will be to explore special provisions for CDx in the new IVDR, outline when industry need to start implementing these special provisions, determine how Notified Bodies are...

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