Audio Conference

New EU Rules for Tissue Engineered Products Dr. Thierry Chignon Principal Consultant Director Quintiles Consulting Europe Purchase recording $199

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After years of discussion, the Commission of the European Union finally published its proposed regulations for Tissue Engineered Products in November 2005. The decision has been taken to place such products under the Medicinal Regulation umbrella with other (already regulated) products such as Somatic Cell Therapy and Gene Therapy medicinal products, creating a new category, namely 'Advanced Therapies Medicinal Products'.

In doing so however, the Commission acknowledged that Tissue Engineered Products require radical adaptations of the existing medicinal product regulation in order to succeed. This presentation will described the scope and specificity of this new regulatory framework, and highlight areas where industry is likely to ask for adaptations. In addition, Dr. Chignon will provide insight into where this new regulation fits within the existing framework of European Directives, so that the participants will better understand how they all work together. The presentation will incorporate several product examples to help attendees better understand this new regulatory framework.

This audio conference will cover:

• Details of the new EU regulations governing tissue engineered products
• Areas where industry may request changes
• The relationship between these new rules and existing EU directives
• How to navigate the regulatory maze!
  

About the speaker:

Dr. Thierry Chignon is a Principal Consultant and Director with Quintiles Consulting Europe. He has over 15 years of regulatory affairs experience, working with many different products including medical devices. Thierry provides strategic advice and practical support for pan-European marketing and helps clients to solve issues related to the European National Authorities.

Thierry has been working for more than five years as an Expert of the Commission of the European Union on medical device regulation. In particular, he has been preparing and negotiating on behalf of the Commission, Directive 2000/70/EC for inclusion of medical devices utilizing human blood derivatives, and has collaborated on the preparation and approval of Directive 2003/32/EC for TSE risk management and Directive 2004/23/EC on human tissue procurement/establishment. He is chairman of the EUCOMED Human Tissue Product Task Force and closely involved with the Commission of the European Union in the preparation and negotiation on this Commission proposal for Advanced Therapy Medicinal Products.

Who should attend?

• Regulatory affairs
• Quality control
• Quality assurance
• International sales and marketing
• Senior management
• Business development
  

This audio conference is classified as General Interest.

Purchase Options:

• Purchase recording and presentation $199