Public consultation

On 30 April 2014, FACT and JACIE published the draft sixth edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration for Hematopoietic Cellular Therapies for public consultation and comment for a 90-day period. Comments will be accepted from April 30, 2014 through July 24, 2014.

Why is this consultation of interest to me?
The public consultation is a critical phase of the development of the Standards. The draft text is the result of significant work and effort by an international group of experts who have reached a consensus. However, the Standards are not designed to be the preserve of a particular group but should be relevant to the wider global transplant community. For this reason, you are strongly encouraged to participate, not least of all because ultimately those affected by the new requirements are the professionals in their day-to-day work.

Who can participate?
Anyone working in the transplant or cellular therapy sector can participate including physicians, data managers, nurses, quality managers, laboratory directors, technicians and operators and regulators. Submission can be made as individuals or groups.
You are also encouraged to distribute this notification among your colleagues for their information. Professional societies, associations or groups are also kindly requested to alert their members to this consultation.

How will I identify changes to the Standards?
The Standards document is a so-called "red line" text where changes are highlighted using the MS Word track changes facility.

So what do I have to do to participate?
To submit comments for the draft FACT-JACIE Standards, follow the steps below. Comments will be accepted until July 24, 2014.
  1. Access the Comment Form at www.surveymonkey.com/s/HCTcomments
  2. Type in your contact information and comments on the form. Fill in all fields so that the Standards Committee fully understands your position.
  3. Submit the form when finished. Once the form is submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted
Key documents

These and additional files also available at the end of this page

What do the Standards cover?
These Standards apply to hematopoietic progenitor cells, defined as self-renewing and/or multi-potent stem cells capable of maturation into any of the hematopoietic lineages, lineage-restricted pluri-potent progenitor cells, and committed progenitor cells from hematopoietic sources (bone marrow, umbilical cord blood, peripheral blood, or other tissue source). These Standards also include mononuclear cells, defined as nucleated cells from any hematopoietic tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as hematopoietic progenitor cells.  The Standards apply to all phases of collection, processing, storage, and administration of these cells, including various minimal manipulations such as removal or enrichment of various cell populations and cryopreservation.

Any questions?
Contact Mr. Eoin McGrath, Operations Manager
JACIE Accreditation Office
Tel: +34 93 453 8711
eoin.mcgrath@ebmt.org


If you have difficulties accessing documents, try to right-click on the link and select 'Save link as..." to your PC as in the image below (exact option depends on your browser e.g. Chrome, IE, Firefox, Safari etc.)





Documents and resources

FACT Webinar on the public consultation
[note that the content of the webinar is the responsibility of FACT]
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Eoin McGrath,
30 Apr 2014, 02:21
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Eoin McGrath,
30 Apr 2014, 02:02
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Eoin McGrath,
30 Apr 2014, 02:01