Guide for the Assessment of Clotting Factor Concentrates
Guide for the Assessment of Clotting Factor Concentrates
Guide for the Assessment of Clotting Factor Concentrates
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TABLE OF CONTENTSPAGEINTRODUCTION 1SECTION 1:<strong>Factor</strong>s Affecting <strong>the</strong> Quality and Safety<strong>of</strong> <strong>Clotting</strong> <strong>Factor</strong> <strong>Concentrates</strong> 3SECTION 2:Licensing, Regulation, and Control <strong>of</strong> <strong>Clotting</strong> <strong>Factor</strong><strong>Concentrates</strong> (Europe and North America) 13SECTION 3:Establishing Licensing, Regulation, and Control Proceduresin Countries Without Well-Established Regulatory Systems 17SECTION 4: Evaluating <strong>Clotting</strong> <strong>Factor</strong> <strong>Concentrates</strong> 21SECTION 5: Safety Aspects <strong>of</strong> Locally Made Small Pool Cryoprecipitate 27CONCLUSION 31APPENDICESAppendix 1: Registry <strong>of</strong> <strong>Clotting</strong> <strong>Factor</strong> <strong>Concentrates</strong> 33Appendix 2: Model Product <strong>Assessment</strong> Questionnaire 43Appendix 3: Glossary 47Appendix 4: WFH Resources 49
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