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: |
| ||||||||
Start date: | 2018 | End date: |
|
Project progress:
Date | Description Action Task | |
---|---|---|
August 21 |
| Paulien afspreken of ze online questionnaire tool wil uitleggen
Project outcome:
Date | Product |
---|
CURRENT QUESTIONNAIRE
...
General information
...
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
...
Would the registry 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
...
We have requirements for affiliated centres in addition to WMDA Standards and applicable national regulations:
If yes, please specify these requirements:
YES / NO
...
ALT/AST:
...
...
...
...
HAV (NAT):
...
Toxoplasmosis:
...
Is the physical and medical exam at donor work up performed by a medical practitioner?
...
Is a Mandatory or a Voluntary National Reporting Scheme available?
If yes, please specify which one:
...
Is a WMDA SEAR/SPEAR Reporting Scheme available:
If yes, please specify which one:
...
28-01-2019 |
|