Industry Update – European Human Tissues Regulation

is being presented by Richard van der Linden, Senior Consultant, with Signifix and airs on Tuesday, November 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.

In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.

This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.

EN 1394:2007 - A New Dawn for Human Tissue in Europe

The previous 18 months has seen a huge leap forward in the regulation of human tissue products, through the publication of the Advanced Therapy Medicinal Product Regulations (ATMP). In parallel, the European Commission has expanded the directive 2004/23/EC into two technical directives, which detail requirements for ensuring public health when using human tissue from donation to distribution.

No longer will Europe be faced with a fragmented regulatory approach to human tissue products, it will have a unified system based on the free movement of human tissue across European borders.

EN 1394:2007 - A New Dawn for Human Tissue in Europe was presented by Phil Brown, Director of Regulatory Affairs, with Wright Medical and aired on 2008-07-02. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Navigating the European Human Tissue Maze

The European regulatory requirements over the past 10 years covering products using human tissue has been more than a little confused. Excluded from the Medical Device Directive, and not always appropriate to pharmaceutical rules, product manufacturers have had to deal with a raft of national regulations ranging from 'non-regulation' to 'medicines regulation'.

Although pan-European regulation has been mooted, the confusion is set to continue for at least two more years. In this audio conference, Phil Brown describes how this maze of regulation came about, as well as how the current European map offers opportunities for product introduction.

Navigating the European Human Tissue Maze was presented by Phil Brown, Sr. Consultant, with Quintiles Consulting on 2005-02-09. For more details on this conference, or to purchase a download, please visit our site www.fxconferences.com