Many companies believe that by simply having the CE mark on their products they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

This audio conference discusses these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition, the presentation covers proper language for the intended users in conjunction with risk management.

This audio conference covers:

• 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

About the speaker:

Dr. Jaap L. Laufer, MD, PharmD, is Vice President, Public & Regulatory Affairs of Emergo Group. He has over 25 years of experience in Regulatory, Quality and Medical Affairs at major pharmaceutical and medical device companies. He serves as Senior Regulatory Counsel to the management or board of several major medical device manufacturers as well as 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.

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 past Chairman of Regulatory Affairs Professional Society (RAPS) Europe, a contributor to Orange County Regulatory Affairs (OCRA) and a visiting teacher to the School of Pharmacy at the University of Southern California. Recently, he was invited as a speaker to the American Academy of Sciences. He is a Member of the Advisory Committee for Borderline and Combination Products (MDEG) to the European Commission in Brussels. 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 Affairs
• Quality Assurance
• Labeling & Documentation
• International Sales & Marketing
• Legal Counsel
• Senior Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.