Sylabus
Lecturers:
PharmDr. Jiří Gregor, Ph.D.
RNDr. Barbora Honegrová, Ph.D.
MUDr. Pavel Měřička, Ph.D.
Mgr. Miroslava Jandová,Ph.D.
Lectures:
History of tissue banks, tissue donation - ethical and legal issues (EU Directives and harmonized national legal norms of the Czech Republic), tissue donation and harvests in living and deceased donors, cell and tissue graft procurement establishment, tissue establishment.SOHO (substance of human origin) establishment Advanced therapy medicinal products.
Principles of preservation methods, hypothermic preservation, deep freezing, cryopreservation, theory of cryoprotection, vitrification and its application in cell and tissue banking, freeze-drying, methods of organ preservation, organ bank.
Safety and quality assurance in practice of tissue establishments. Contraindications of tissue harvests, laboratory testing of donors and processed tissue grafts, importance of using clean room technology for safety of tissue transplantations,quality and safety assurance systems, Quality and safety in the practice of the organ bank.Thew role of Europrean Union and European Councul instututions in the quality and safety assurance for substances of human origin.
Seminars:
Application of tissue grafts and advanced therapy medicinal products in different medical disciplines - surgical disciplines, hematology and oncology. Methods of risk assesment and risk management in cell and tissue banking and transplantation. Cellular therapy based on application of advanced therapy medicinal products
Practical courses:
Organisation of tissue harvests in living and deceased donors, donor suitability - practical examples, demonstration of preservation methods and tissue grafts, documentation on tissue harvest and application ofr tissue grafts. Use of clean room technology in processing of cell and tissue grafts, organ bank. Use of Single European Code (SEC) for labeling tissue establishment products.List of ISBT 128 codes for cell and tissue products.European Union tissue establishment coding platform
Cryopreservation of cells and tissues, use of cell culture in clinical situations, advanced therapy medicinal products -manufacturing and clinical application, human milk bank, application of the system of Hazard Analysis and Critical Control Points in practice of tissue and milk banks.Human milk pasteurization and alternative methods of human milk processing.
Anotace
History of tissue banks, tissue donation - ethical and legal issues, the terms of tissue and SOHO establishments.Tissue donation and harvest in living and deceased donors- principle of voluntary and unpaid donation. Cell and tissue processing.
Principles of cell and tissue preservation methods, hypothermic preservation, deep freezing,cryopreservation,freeze-drying.Theory of Cryoprotection. Safety and quality assurance in practise of tissue establishments.
Contraindications of cell and tissue harvest, laboratory testing of donors and of processed cell and tissue grafts, importance of using clean room technology in cell and tissue processing for the safety of tissue transplantation. Advanced therapy medicinal products manufacturing and clinical application.The role of European Union and European Council Institutions in the quality and safety assurance of substabces of human origin.