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Legal and regulatory framework for tissue and cell banking

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Danielailcenco

The document discusses the legal and regulatory framework covering tissue and cell banking activities in Europe. It outlines several EU directives and regulations that establish standards for quality and safety. It also describes national legislation in various European countries governing issues like consent requirements, public versus private banking, and restrictions on import/export. National laws cover donor screening, facility requirements, traceability, and quality management systems that tissue banks must implement.

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2. Legal and regulatory framework covering tissue and cells banking activities
Legislation ,[object Object],[object Object],[object Object],[object Object],[object Object]
EU Legislation (1) ,[object Object]
EU Legislation (2) ,[object Object],[object Object]
EU Legislation (3) ,[object Object]
EU Legislation (4) ,[object Object],[object Object]
Directives covering equipments ,[object Object],[object Object]
EU regulatory framework ,[object Object],[object Object],[object Object]
Consent Presumed consent Slovenia Informed consent The Netherland Presumed consent Luxemburg Informed consent Germany Presumed consent Belgium Presumed consent Austria Legislation Donors legal situation Country
Types of TCO ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Independent and /or private banks ,[object Object],[object Object]
National legislation covering tissue and cells banking activities (1) ,[object Object]
National legislation covering tissue and cells banking activities (2) ,[object Object],[object Object]
National legislation covering tissue and cells banking activities (3) ,[object Object]
National legislation covering tissue and cells banking activities (4) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
National legislation covering tissue and cells banking activities (5) ,[object Object]
National legislation covering tissue and cells banking activities (6) ,[object Object],[object Object]
National legislation covering tissue and cells banking activities (7) ,[object Object]
Legislation covers: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Legislation covers: ,[object Object],[object Object],[object Object]
Legislation covers: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Storage (1) ,[object Object],[object Object],[object Object]
Storage (2) ,[object Object],[object Object]
Storage (3) ,[object Object],[object Object]
Segregation — tissues ,[object Object]
Segregation — transmissible disease agents and markers ,[object Object]
Traceability ,[object Object],[object Object]
Unique identification code number for each CTBO ,[object Object],[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (1) ,[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (3) ,[object Object],[object Object],[object Object],[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (4) ,[object Object],[object Object],[object Object],[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (5) ,[object Object],[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (6) ,[object Object],[object Object],[object Object],[object Object]
QUALITY ASSURANCE SYSTEM (7) ,[object Object],[object Object],[object Object],[object Object]
Import/Export legislation for CTO ,[object Object]
2004/23/EC ,[object Object]
Important: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Legal and regulatory framework for tissue and cell banking

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