2nd Annual European IVD Performance Evaluation & Regulatory Conference, 6-7 February 2012, Belgium

Main Category: Conferences
Article Date: 22 Dec 2011 - 0:00 PST


This February, Q1 Productions will follow up and expand upon the success of its first European IVD Performance Evaluation Conference & Regulatory Conference. Throughout Europe, diagnostic corporations are continually developing new and groundbreaking diagnostic tests that are revolutionizing the method in which patients are diagnosed, as well as the way decisions are made regarding the course of treatment. Although the industry is well established throughout the continent, regulators have been slow to provide concrete guidance to these innovative companies on regulatory clearance, as well as on the performance evaluations that ultimately guide companies, users and regulators on the appropriate and intended use for the product. In the 2nd Annual IVD Regulatory & Performance Evaluations Conference, speakers and participants will experience an unrivaled opportunity for discussion and debate that is focused most specifically on the diagnostic market - a truly one of a kind program that highlights the challenges so specific to this industry.

With the IVD Directives still in flux, several sessions will be dedicated to forthcoming directive updates, and how companies can not only prepare for these changes, but also implement the changes in a straightforward and comprehensive manner. Through perspectives ranging from the European Commission to Notified Bodies and industry experts, the program will provide the well-rounded approach required when addressing such evolving standards. Key areas to watch, along with recast timelines and implementation approaches will be central to these sessions.

Performance evaluations will also be discussed during this program, covering a wide range of topics, from initial study design considerations to sample sizes and practical considerations in sample disposal. Challenges faced in conducting this type of research for diagnostic tests are tremendous and entirely different from the challenges faced by pharmaceutical and device corporations in their clinical research. Focusing on diagnostic performance evaluations and covering the full range of study design through publication and use will provide participants with the critical information required to succeed in this market.

Like all Q1 programs, the focus will not only include educational sessions, but also formal and informal networking opportunities through various coffee and luncheon breaks, as well as sessions aimed at group discussion.

For more information visit: http://www.q1productions.com/EUDxReg

When: February 6 - 7, 2012

Where: Brussels, Belgium

Who: This conference is ideal for senior-level executives working within diagnostic corporations to commercialize new diagnostic tests though CE Marking and the execution of performance evaluations to support CE Mark. Those that require a full understanding of the implications of new directives will also find this event a must attend.

Presenting organizations include: BD Diagnostics, BSI, Dako, DNA Electroincs, Immunodiagnostic Systems, Jones Day, Lawford Davies Denoon, Paul Ehrlich Institute, Qarad, Qiagen, SGS United Kingdom Limited, Siemens AG, Sysmex Europe and Tecan

About the Organizer

Q1 Productions designs and develops webinars, training courses, conference programs and forums aimed at specifically targeted audiences in order to provide strategic and timely information. Through a rigid production process focused on end-user research and design, our team is able to understand the immediate business concerns of today's leading executives. Whether focusing on new or pending legislative issues, enhanced business processes or technologies that will drive efficiency and customer service, our programs provide solutions to the urgent needs of our attendees. Visit http://www.q1productions.com

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