Audio Conference

EU Device Labeling: Issues and Requirements Dr. Jaap Laufer V.P. Public & Regulatory Affairs Emergo Group Inc. Recording - US$199

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For many companies, achieving ISO 13485 certification, applying the CE mark and finally exporting to Europe is a great victory. However, many companies forget that the EU is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with language requirements and the use of symbols for each country. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three? In this presentation, we will discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels.

This audio conference will address:

• Specific language requirements for all EU member states
• Current and future use of e-Labeling as allowed by the EU
• Language requirements for patient versus professional use
• Using EN 980 symbols; can you create your own?
• Legal requirements versus minimizing your risk

Speaker biography:

Dr. Jaap L. Laufer MD PharmD has over 20 years of experience in Regulatory and Medical Affairs at major pharmaceutical and technology-intensive medical device companies. He serves as Senior Regulatory Counsel to the management or board of several major medical device manufacturers and venture capital funded companies.

In previous positions, he was VP of Regulatory and Clinical Affairs for LipoMatrix, Inc. in Neuchatel, Switzerland. When Collagen Corp. of Palo Alto, CA, acquired LipoMatrix, he became their Vice President Regulatory Affairs. Before he joined LipoMatrix, Dr. Laufer held a number of managerial positions of increasing responsibility within Pfizer. In this capacity he was responsible for regulatory approval and compliance, and medical matters concerning a wide variety of active and non-active medical devices.

On top of being an experienced auditor for compliance with ISO and FDA Quality System Regulations, Dr. Laufer has managed many clinical studies, sometimes from inception to publication. He is a regular contributor and past Chairman of Regulatory Affairs Professional Society Europe (1993-1996) and a visiting teacher to the School of Pharmacy at the University of Southern California. He has a PhD in Pharmacy from the University of Groningen and a PhD in Medicine from the University of Nijmegen, both in The Netherlands.

Who Should Attend?

• Regulatory managers
• Quality assurance managers
• International sales managers
• In-house legal counsel
• Senior management
  
  This audio conference is rated General Interest.
  

Purchase Options:

• Purchase a recording of this event US$199