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SELECTBIO Conferences Companion Diagnostics

Sylvie Le Gledic's Biography



Sylvie Le Gledic, Director IVD/CDx, Voisin Consulting Life Sciences

Sylvie Le Gl├ędic is Director IVD/CDx at Voisin Consulting Life Sciences (VCLS), France. Sylvie brings over two decades of experience in the regulatory field of in vitro diagnostic (IVD) medical devices. At Voisin Consulting, she is in charge of the design and implementation of global regulatory strategies for the development and registration of in vitro diagnostics medical devices (IVDs). Sylvie helps IVD manufacturers in the creation of CE mark technical files and US regulatory dossiers for FDA approval, advising on the required Quality Management System. She assists pharmaceutical companies developing Companion Diagnostics (CDx) in the drug/CDx co-development context and facilitates liaison between both pharmaceutical and diagnostic developers. She is actively involved in the evolution of the EU IVD regulation, and closely follows the new rules for regulatory approval of CDx both in EU and US.

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Current and forthcoming EU Regulations Surrounding in vitro Companion Diagnostics

Monday, 27 October 2014 at 13:30

Add to Calendar ▼2014-10-27 13:30:002014-10-27 14:30:00Europe/LondonCurrent and forthcoming EU Regulations Surrounding in vitro Companion DiagnosticsSELECTBIOenquiries@selectbiosciences.com

It is generally recognized that the current European in vitro Diagnostic (IVD) Directive presents a certain number of weaknesses, and more particularly its inadequate classification system (based on positive lists), that leads to an insufficient level of scrutiny for many medium to high risk IVD tests. On September 26th, 2012, the European Commission (EC) released the first draft of the new EU regulation for in vitro diagnostic medical devices (IVDs). Compromised amendments have then been voted in September  2013 by the European Parliament (EP) with an expected date of adoption by mid-2015.  The Companion Diagnostics (CDx) will be classified as high risk devices and specific requirements will be added to get these products CE marked. This presentation will describe the anticipated additional requirements that will apply to CDx in Europe and the practical implications for IVD test and drug developers. A parallel with the current FDA requirements on CDx will also be discussed for integration and provision of both specificities in a more international development.


Add to Calendar ▼2014-10-27 00:00:002014-10-28 00:00:00Europe/LondonCompanion DiagnosticsSELECTBIOenquiries@selectbiosciences.com