Project details:
Project group: | Deliverable D6.1 (2018) | ||||||||
Project group chair: | PaulienEsther Pustjens | ||||||||
Project group members: | - | ||||||||
| Project office supporter: | Lydia Foeken and Esther Pustjens | ||||||||
| Project description: | Questionnaire to collect regulatory information from EU Member States, to be used in 2019 | ||||||||
| Product: | Websites, patents filling, etc. | ||||||||
| Project status: |
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| Start date: | 2018 | End date: |
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Project
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Date
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Description Action Task
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- Survey ontwikkelen om te checken of regulatory information compleet is (naar EU registries)
- Paulien afspreken of ze online questionnaire tool wil uitleggen
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outcome:
Date | Product |
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CURRENT QUESTIONNAIRE
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General information
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PROPOSED QUESTIONNAIRE
Introduction
The EU has a common set of standards to ensure the quality and safety of:
- organs for transplantation, and
- tissues and cells for human use, including reproductive cells
For EU registries to import cells into a EU Member State the EU Member States must be able to ensure that cells imported under their licences meet the quality and safety requirements set out in the EU tissues and cells Directive 2004/23/EC and its implementing Directives, including 2006/17/EC and 2006/86/EC.
Instructions for completion
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General information
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If yes, please specify:
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The registry is accredited by any other organisation:
If yes, please fill in the organisation:
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The registry would be able to provide a full list of name/addresses of each affiliated and their licence/accreditation status, on request:
Tip: you can upload the full list here and make it available for the WMDA membership
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The Cord Blood Banks are FACT-NetCord accredited:
If yes, which cord blood bank(s)?
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The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations:
If yes, please specify these requirements:
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Timeframe before stem cell donation date (for donors) or
Timeframe when the materials sample is taken for testing (for cords)
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ALT/AST:
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HAV (NAT):
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Toxoplasmosis:
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Testing
Please indicate whether the following are completed on the donor during the medical examination:
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All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:
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HLA typing for patient specific request is performed in an appropriately accredited laboratory:
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Customs regulations
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Are there any customs regulations to follow, or customs paperwork required, to import cell products to your country? If yes, please specify:
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Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify:
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Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify:
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Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify:
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Reporting of Serious Adverse Events
Please indicate which of the following schemes for reporting Serious Adverse Events relating to either the Donor or the product the Registry participates in:
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Voluntary National Reporting Scheme
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WMDA SEAR/SPEAR Reporting Scheme:
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Quality management
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Would you be willing to provide these to WMDA or another registry upon request?
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Would you be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in?
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28-01-2019 |
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