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
