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.

This audio conference covers:

• Major differences in dossier requirements for human tissue and cell products
• Practical implications on the quality system and the day-to-day operations of a tissue establishment, as well as test laboratories
• Serious adverse events, serious adverse reactions, recall definition and reporting
• Third-party agreements
• Comparison between the role of responsible person and qualified person
• Specific strategies and implications on importing human tissue and cell products from a non-EU country
• The relationship between the EUTCD and the Advanced Therapy Medicinal Products (ATMP) regulation

About the speaker:

Richard van der Linden is senior QA and RA consultant at Signifix B.V., a company specializing in RA and QA in complex medical devices, human tissue product and ATMPs. Richard has more than 12 years of experience in biotechnology, ranging from research to production and quality management. He has combined knowledge and expertise in quality management, manufacturing and science, in both the pharmaceutical and food sector, and provides strategies and support for implementation, optimization and trouble-shooting in quality assurance, product development and regulatory affairs. His spearpoint is human tissue and cell products and Advanced Therapy Medicinal Products. He is Responsible Person in several different Tissue Establishments and has led international Tissue Establishment licensing activities (including inspections) and strategies.

Who should attend?

• Senior Managers of Storage and Distribution
• Senior Managers of International Distribution
• Responsible Persons (Designated Individuals)
• RP (DI) Delegates
• Tissue Establishment Personnel
• Regulatory Affairs
• Clinical Operations
• Quality