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 progress:
Date | Description Action Task | ||
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August 21 |
| Survey ontwikkelen om te checken of regulatory information compleet is (naar EU registries)December 3 | Former WMDA staff member vrijdag 7 december uploaden questionnaire; openbare pagina onder global development pillar information |
Project outcome:
Date | Product | ||||||
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28-01-2019 |
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CURRENT QUESTIONNAIRE
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General information
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Collection procedure
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Are procedures in place to minimize microbiological contamination during collection?
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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
General information
If yes, please specify:
The registry is accredited by any other organisation:
If yes, please fill in the organisation:
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
The Cord Blood Banks are FACT-NetCord accredited:
If yes, which cord blood bank(s)?
The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations:
If yes, please specify these requirements:
Timeframe before stem cell donation date (for donors) or
Timeframe when the materials sample is taken for testing (for cords)
ALT/AST:
HAV (NAT):
Toxoplasmosis:
Testing
Please indicate whether the following are completed on the donor during the medical examination:
All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:
HLA typing for patient specific request is performed in an appropriately accredited laboratory:
Donor clearance to donate is confirmed by a medical doctor, following as a minimum the donor exclusion criteria in Annex 1 of EU Directive 2006/17/EC:
The party providing the Cell Product must exclude Donors when:
- They are pregnant;
- They are breastfeeding;
- There is the potential for transmission of inherited conditions;
- There is evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration Donor travel and exposure history and local infectious disease prevalence;
- There is presence on the Donor’s body of physical signs implying a risk of transmissible disease(s);
- There is a history of a disease of unknown aetiology;
- There is a risk of transmission of diseases caused by prions;
- There is systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated;
- There is history of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the Cell Product;
- There is recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist;
- There is ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.
Customs regulations
Are there any customs regulations to follow, or customs paperwork required, to import cell products to your country? If yes, please specify:
Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify:
Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify:
Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify:
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:
Voluntary National Reporting Scheme
WMDA SEAR/SPEAR Reporting Scheme:
Quality management
Would the registry be willing to provide these to WMDA or another registry upon request?
Would the registry be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in?