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 describes the scope and specificity of this new regulatory framework, and highlight areas where industry is likely to ask for adaptations. In addition, Dr. Chignon provides 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 incorporates several product examples to help attendees better understand this new regulatory framework.
New EU Rules for Tissue Engineered Products was presented by Dr. Thierry Chignon, Principal Consultant & Director, of Quintiles Consulting Europe. This audio conference aired 2006-03-16 and is available for download at www.fxconferences.com
