News

See also Events for training courses and other events of interest.

Feedback on HSCT standards requested for preparation of next edition

posted 19 Apr 2016, 07:43 by Eoin McGrath   [ updated 19 Apr 2016, 07:48 ]

The FACT-JACIE Standards Committee will begin drafting the 7th edition International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration Standards in June 2016. FACT and JACIE invite you to complete a short survey focusing on general concepts of interest.
You are also encouraged to promote this survey in your national or regional professional society. The results of this survey will be reported to the Standards Steering Committee for review and consideration. Input from programs, facilities, and individuals performing cellular therapy helps maintain the clarity, usefulness, and relevance of the Standards.
Responses will be accepted through May 15, 2016.
 
www.surveymonkey.com/r/FACT-JACIE7thEDSurvey

JACIE Training Course, Barcelona 6-7 October 2016

posted 15 Apr 2016, 01:28 by Eoin McGrath   [ updated 15 Apr 2016, 01:29 ]

JACIE will host a training course in Barcelona in October. More details can be found here.

Note that an additional event is being scheduled for Nijmegen, The Netherlands for 27-28 October 2016. More details will be announced shortly.

Post-EBMT 2016 - JACIE

posted 8 Apr 2016, 01:48 by Eoin McGrath   [ updated 8 Apr 2016, 01:55 ]

Thanks to everyone who attended the quality sessions and especially to all of the speakers. Feedback was great even if the room was sometimes a bit noisy. We have some ideas for 2017 in Marseille.
Anyone who attended can get access at no cost to all of the slides via the eMaterials service e-materials.com/ebmt2016.

A nice video was also made as part of EBMT TV featuring Prof. John Snowden and Dr. Riccardo Saccardi explaining why they think that quality and accreditation are important for transplantation. See it on YouTube below.

EBMT TV video on JACIE


Nature | News: "How quality control could save your science"

posted 1 Apr 2016, 08:58 by Eoin McGrath

Nice piece from Nature (27-01-2016)
"Having data that are traceable — down to who did what experiment on which machine, and where the source data are stored — has knock-on benefits for research integrity"
Access the article here.

English-Spanish glossary of quality management terms

posted 5 Feb 2016, 02:42 by Eoin McGrath   [ updated 5 Feb 2016, 02:43 ]

The Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA) and Worldwide Network for Blood & Marrow Transplantation (WBMT) along with the Latin American Group for Bone Marrow Transplantation (LABMT) have facilitated the preparation of a simple glossary of quality management terminology to help create awareness and understanding of basic but important quality management terminology among Spanish-speaking transplant professionals. The glossary can be accessed at www.ahcta.org/documents.html.

JACIE Training Course, UK - 2-3 June 2016

posted 27 Jan 2016, 07:48 by Eoin McGrath

JACIE will hold a training course near Southampton, UK on 2-3 June 2016. Full details are available at https://ebmt.stagehq.com/events/3560.

Another training course for early October 2016 in Barcelona, Spain will be announced shortly.

JACIE introduces new fees and agreement document for applications.

posted 5 Jan 2016, 02:18 by Eoin McGrath   [ updated 9 Feb 2016, 04:11 ]

From 1 January 2016, centres submitting applications for accreditation will be required to sign an agreement with the EBMT which covers all aspects of the accreditation process. The agreement sets out the rights and obligations of both organisations during the process. This agreement replaced the previous terms and conditions document.
The document entitled 'F-009-01-Standard Agreement for JACIE Accreditation' can be accessed in the Document Centre in the 'Applicants' section.

New applications must also be completed using the updated application form, also available in the Document Centre.

Both documents are also linked below.

New fees will also be applied from 3 April 2016. See here for more information.

Dr. Riccardo Saccardi appointed as new JACIE Medical Director

posted 14 Dec 2015, 08:52 by Eoin McGrath

The EBMT is pleased to announce the appointment of Dr. Riccardo Saccardi as the new JACIE Medical Director. Dr. Saccardi will take over from Prof. John Snowden with effect from 1 January 2016. The appointment follows an open recruitment process launched in October which led to three candidates being shortlisted for interview. The high quality of all of the candidates made the decision very difficult and we are grateful to everyone who participated.

Dr. Saccardi has been involved in the field of Haematopoietic Stem Cell Transplantation since his specialization in Haematology and has worked in the clinical, laboratory and cord blood bank areas. His centre has successfully implemented both the ISO and FACT-JACIE Standards. 

In 2003, he participated in one of the first JACIE inspector training courses and since then has regularly participated in JACIE inspections, mostly in clinical facilities and often as team leader. He also regularly attends the annual courses organized by the Italian Transplant Agency (CNT) for training inspectors for the national accreditation program, based on the JACIE standards.

In addition to day-to-day haemato-oncology and HSCT practice, his main academic interest has been severe autoimmune diseases and he has led and contributed to various national and international networks, both in the clinic and in the lab including cooperative studies for the standardization of graft quality both in cord blood and peripheral blood stem cells. In this way, Dr Saccardi is not only well positioned to advise on routine aspects of HSCT, but also his expertise will help develop JACIE’s perspective of new cellular therapies.

He firmly believes that rules and regulations in all fields of clinical medicine must continuously evolve, updating clinical practice from experimental medicine and promoting standardization across countries. He considers that JACIE has been a very important tool to both increase the safety of procedures and promote the homogenization of clinical practice of HSCT in Europe and further afield. He also believes that the development and management of regulations must be carried out through close interaction between quality management specialists and clinical professionals involved in daily practice, keeping the standards as close as possible to the field of transplantation.

We look forward to supporting Dr. Saccardi in his new role and to bringing his experience and knowledge to bear on the continuous improvement of the Standards and the accreditation process for the benefit of patients, donors and transplant professionals.

Selected membership and participation
  • Member of EBMT (CIC 304)
  • Member of the Board of the Italian HSCT Society (GITMO)
  • Coordinator of the GITMO Cell Processing section
  • Member of Italian Health Authority Committee for the implementation of the Unique Identification Code System of Tissues and Cells for Human Application
  • Member of the Working Group (WG) promoted by the European Directorate for the Quality of Medicines and Healthcare (EDQM) preparing the 3rd edition of the Guide to the Quality and Safety of Tissues and Cells for Human Application.
  • Dr. Saccardi was a member of the EBMT Board for 8 years which gave him both an insight into the Society and an overview of HSCT across Europe. 
Dr. Saccardi is based at the Azienda Ospedaliero Universitaria Careggi Largo Brambilla n° 3 – 50134 Firenze, Italy

Changes in the JACIE Accreditation Process for 2016

posted 30 Nov 2015, 03:41 by Iris Bargallo   [ updated 30 Nov 2015, 03:47 ]

JACIE has reviewed the current Accreditation process with the objective to improve and optimize the process for all parts involved. Our goal is to make the process shorter for centres that are already well prepared for the accreditation and to identify the centres that need more time and support from the JACIE Office to prepare their application sufficiently in advance of any eventual inspection.

Therefore the following changes will be introduced with effect from 1 January 2016: 

  • Applicant centres will be required to formally accept a quotation for the fees. This will make clear the scope of the accreditation and related costs at the earliest possible point in the process in order to avoid misunderstandings and time-consuming corrections at a later date.
  • Applicants must sign an agreement with the EBMT (JACIE’s parent organisation) once the application for Accreditation is approved. This document outlines the responsibilities both of JACIE and of the centre. 
  • Applicant centres will be required to submit the Pre-audit documentation within 30 days from receipt of the service agreement signed by the centre’s representative. Where an applicant delays more than 30 days in submitting the pre-audit documentation, the accreditation process of the centre will be considered expired and the centre must restart the process

You will find the process in detail in the applicant's flowchart and in the JACIE Inspection guide, both documents can be downloaded from the Document Centre in this website.

If you have any queries, please do not hesitate to contact the JACIE Office.

EDQM Survey on Tissues and Cells Guide 2015

posted 25 Nov 2015, 06:44 by Eoin McGrath   [ updated 17 Dec 2015, 02:14 ]

The EDQM Guides are excellent and accessible sources for help on all aspects associated with tissues and cells including HSC. EBMT experts have contributed to the Guides in the past and to the 3rd edition which is currently in preparation.
The review committee have launched a survey to help them understand how it has been accessed and used in the past. You are now invited to participate in this review by completing the survey. The survey is expected to take between 5-10 minutes to complete.

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