See also Events for training courses and other events of interest.
JACIE introduces a new version of the Checklist which reflects QM inspector inclusion in the inspection teams
From September 1st, 2016, centres submitting applications for accreditation or re-accreditation will be required to submit version 9 of the checklist (CH-001-09-Inspection Checklist). The contents of the checklist have not been modified since the publication of the 6th edition of the Standards. In this new version, QM Standards have been separated into individual sections of the Checklist to better manage the inclusion of the QM inspector into the inspection teams.
This version replaces all previous versions and older versions of the checklist will not be accepted after August 31st, 2016. Given that the contents of the checklist remain without change and have only been reorganized, if needed it should not be difficult to transfer the information from an older version of the checklist into the current one. Centers that might have started working on an older version are kindly requested to transfer the information to the current version.
Please note that the checklist includes an Instructions section. A brief tutorial for the current version of the Checklist will be available in the Fall. In the meantime, if you have any questions regarding the checklist please do not please do not hesitate to contact the JACIE Office.
The checklist entitled 'CH-001-09-Inspection Checklist' can be accessed in the 'Document Centre' in the 'Checklist' section.
Also by clicking HERE.
The ECDC has published a guide on Zika virus preparedness. The objective of the document is to guide the preparation and implementation of national preparedness plans for the safety of substances of human origin during outbreaks of Zika virus infection, both in affected and non-affected areas.Access the guide at /ecdc.europa.eu/en/publications
The document includes key elements to be considered in the risk-based decision-making process of mitigating the threats to the safety of substances of human origin posed by Zika virus. It also identifies supporting tools and information sources available at the EU level, either from ECDC or the European Commission’s Directorate-General for Health and Food Safety.
Mapping of More Stringent Tissues and Cells Donor Testing Requirements - Mapping Exercise 2015More
Directive 2004/23/EC defines the mandatory tests that must be performed on tissues and cells donors each time they donate. The legal basis of this legislation allows Member States to adopt more stringent measures on a national basis. Implementation surveys have indicated that many Member States have done this, in some cases in response to local epidemiological risks and in some other cases because they consider that a higher level of safety can be ensured with these more stringent provisions. The more stringent measures are either adopted in national legislation and/or they are defined by national standards organisations to be taken into consideration by authorities in their regular inspections.
The JACIE team recently increased to four F.T.E.* with the arrival of Áurea Villar to the team starting this week. Áurea is filling the newly created position of HR (Volunteers) Coordinator. This new role will focus on the critical volunteer contribution that makes JACIE the success story it is today - inspectors particularly but also committee members.* Full-time equivalent
Áurea is from Barcelona. She studied Law and later completed a Masters in HR in 2012. She worked as a lawyer but a career change took her to Médecins sans Frontières where she worked as a HR coordinator for more than 6 years, both in headquarters and Africa.
Áurea brings to JACIE her multicultural experience, her knowledge in HR strategies for recruitment and retention, but most of all how to empathise, connect and take care of people. Do not be surprised if you hear from her over the coming months as she starts to gather information, opinions and impressions on the role of volunteers.
Note that the content will be delivered in English and Dutch.
A JACIE Training Course will take place in Nijmegen, The Netherlands on 27-28 October 2016 with Dutch Quality Network Hematology (NKH) support.Go to registration at https://ebmt.stagehq.com/events/3788.
Access the document here at the ICCBBA website.
This Circular is intended to provide general information to those who administer cellular therapy products, and serves as an extension and enhancement of the label found on the cellular therapy product.It was prepared jointly by the AABB, America’s Blood Centers, the American Association of Tissue Banks, the American Red Cross, the American Society for Apheresis, the American Society for Blood and Marrow Transplantation, the College of American Pathologists, the Cord Blood Association, the Foundation for the Accreditation of Cellular Therapy, ICCBBA, the International Society for Cellular Therapy, the Joint Accreditation Committee of ISCT and EBMT, the National Marrow Donor Program, and Netcord.
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.
Due to ongoing interest, responses will continue to be accepted up to July 1, 2017.
Nice piece from Nature (27-01-2016)Access the article here.
"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"
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