| Title |
Updated |
Link |
| Mission
statement |
|
 |
| Towards
a Global Standard for Donation, Procurement, Testing, and Distribution
of HSC and Related Cellular Therapies Position Paper (revised 27 May
2008) |
27-05-2008 |
|
|
|
|
| Comparison of Cellular Therapy Standards |
|
|
Crosswalk documents.
Note:
These crosswalks were prepared for the purpose of providing basic
information on organizational activities for global comparison and gap
analysis. They ares NOT intended to be used as a reference or source
document and are not endorsed by any of the participating
organizations. All standards are undergoing revision at the time
of web posting. Efforts will be made to update the information as
soon as possible. Users are directed to each organization’s
standards and accreditation policies for reference and the crosswalk
should not take the place of a thorough line-by-line review of the
Standards. |
|
|
| 1 Donor standards |
29-10-2010 |
|
| 2 Definitions |
24-01-2012 |
|
| 3 Regulation & Inspection |
13-09-2010 |
|
| 4 Quality Management standards |
15-07-2011 |
|
| 5 Cell Collection standards |
14-10-2011 |
|
| 6 Labelling & Coding |
07-06-2010 |
|
| 7 Cell Processing |
15-07-2011 |
|
|
|
|
| Surveys |
|
|
| Import
& Export Requirements |
|
 |
This import-
and export survey was originally started in 2003. In
2009 WMDA began updating the data and you are invited to
participate here.
The data already collected by this survey is available on
the WMDA website under
'Regulatory'. |
|
|
|
|
|
| EU
Directive 2004/23/EC requirements for products sources from third
countries. |
|
|
The EU Directive 2004/23/EC (article 9)
says:
Member States shall take all necessary measures to ensure that all
imports of tissues and cells from third countries are undertaken by
tissue establishments accredited, designated, authorised or licensed
for the purpose of those activities, and that imported tissues and
cells can be traced from the donor to the recipient and vice versa in
accordance with the procedures referred to in Article 8. Member States
and tissue establishments that receive such imports from third
countries shall ensure that they meet standards of quality and safety
equivalent to the ones laid down in this Directive.
AHCTA supports the creation of an international
registry of tissue and cell establishments in order to facilitate this
international movement of tissues and cells..
The Collection Center Data Form
document is a first step in supporting this international registry. We
ask that you can send this document to the collection centres you are working with or fill it in yourself. WMDA will put
the information in an international registry database, so that you can
easily retrieve the information. |
|
|
|
|
|
| Slides
|
|
|
| EBMT Congress, 2011, Paris |
|
|
| Harmonising Standards in SCT: An Update on AHCTA Initiatives |
06-04-2011 |
|
|
|
|
| Tandem Meetings, February 20, 2011 |
|
|
| Harmonising Standards in SCT: An Update on AHCTA Initiatives |
20-02-2011 |
|
|
|
|
| AHCTA
meeting, Goteborg, Sweden, 31
March 2009 |
|
|
| Overview and
Standards Comparison (Derwood Pamphilon, JACIE) |
31-03-2009 |
|
|
|
|
| EU
Commission-Competent Authorities Meeting, 30th May 2008, Brussels |
|
|
| Import-export
issues for HPC (Ineke Slaper-Cortenbach, JACIE) |
30-05-2008 |
|
| |
|
|
| ISCT
Annual Meeting, Sydney, June 27, 2007 |
|
|
| AHCTA Special Session at
the ISCT meeting |
|
|
| Introduction |
27-07-2007 |
|
| EU
regulations for import and export of cellular therapy products |
27-07-2007 |
|
| US Regulations for
Import and Export of Cell Therapy Products |
27-07-2007 |
|
| |
|
|
| FACT-JACIE-TGA
workshop |
|
|
| Implementing
Standards Across International Borders (Linda Kelley, FACT). |
27-07-2007 |
|
| Implementing
Standards Across International Borders: The European experience(Ineke
Slaper, JACIE) |
27-07-2007 |
|
| Australian
experience in using international standards for cell therapies |
27-07-2007 |
|
