Within the Eustite (European Standards and Training in the Inspection of Tissue Establishments) project, the first "Inspector Training Course" started in June with the first e-learning module. The first residential course will be in Vienna, Austria, in September. For the first course participants from 13 European countries are registered. An unitised valuation during the inspections will be an important step to get the aim of similar quality and safety of human tissues and cells that are applied to patients for therapeutic purposes in the member states. One further objective of the course is to give an assistance for understanding and interpretation of the EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC and to differentiate between the products coverd by these directives and the products gathered by the Advanced Therapy Medicinal Products Regulation 1394/2007.
Three subsequent courses, located in Bulgaria (1-3 December 2008), Denmark (27-30 April 2009), and Italy (September 2009), will follow . The second course, from 1-3 December 2008 in Bulgaria is opened for nomination of participants from competent authorities until 1 September 2008. The appropriate e-lerning module will last from 6 October 2008 until 23 November 2008. Every course will have 15 spaces for inspectors or trainee inspectors from authorities of the member states. Detailed information, like the form for nomination, you will find here.
Furthermore, the final version of the "Guideline for the Inspection of Tissue and Cell Procurement and Tissue Establishments" is now available as printed version. It includes several minor editorial changes. The PDF version at the Eustite website is replaced with the text of the printed booklet.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)