See also Events for training courses and other events of interest.
9th Meeting of the Quality Management Group - case study submission
The programme for the EBMT 2017 Annual Meeting is being prepared with a draft programme now online at www.ebmt2017.org/program. For the Meeting of the Quality Management Group, there will be a new format based on real-life cases presented by centres.
Case will be presented in two workshops under two topics:
The selected case studies will be added to the final program and each speaker will make a 10-minute presentation. The speakers will receive free registration for the congress as well as travel and accomodation for 2 nights.
Anyone interested should send an abstract of 250 words maximum to email@example.com.
The JACIE Quality Managers Committee will make the selection.
Don’t hesitate to make the most of this opportunity to share your experience with an international audience.
Deadline for submission: 21/11/2016
JACIE has opened a public consultation on proposed interim standards to cover the administration of immune receptor cells. The proposed standards originated with FACT earlier in 2016 where centres in the USA are increasingly handling these types of therapies. In Europe, provision of these therapies is still in very early stages but more activity in this area is being observed and we consider that this is a good opportunity to anticipate future demand.Production of these cells is not contemplated in these standards.
The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others. The proposed requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.
The interim standards would be added to the 6th edition and come into effect from 2017 being applicable only to centres administering such therapies. Where they are not being provided, these standards would be considered non-applicable.
The deadline is 11 November 2016.
Access the survery at https://www.surveymonkey.com/r/2016-interim-stds
The long-awaited Single European Coding (SEC) system for tissues and cells is closer to being fully implemented. EU Member States are required to transpose the provisions of Directive (EU) 2015/565 into their national legislation by 29 October 2016 and then should apply the requirements on the SEC from 29 April 2017.
The ICCBBA, the organisation behind ISBT128, has prepared a guide "Simultaneous Implementation of the Single European Code and ISBT 128".
To support the SEC, the EU Commission has launched the EU Coding platform. The platform will allow public, free of charge access to the EU Tissue Establishments Compendium and the EU Tissue and Cell Product Compendium.
The link to the EU Coding Platform is available here: https://webgate.ec.europa.eu/eucoding/.
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.
The FACT-JACIE Standards, 6th edition, describe the academic requirements for the position of Processing Facility Director (PFD):
D3.1.1 There shall be a Processing Facility Director with a medical degree, doctoral degree, or equivalent degree in a relevant science, qualified by a minimum of two (2) years training and experience for the scope of activities carried out in the Processing Facility.
A doctoral degree including a medical degree is considered as the ‘gold standard’ of scientific and medical achievement. However, the term doctoral degree is not applied in a uniform fashion in all countries. The Guidance to Standard D3.1.1, 6th edition FACT-JACIE Standards reads:
… Some regions of the world may have degrees that are equivalent to the doctoral degree. If a Processing Facility Director has such a degree, significant and compelling information regarding the degree requirements must be submitted to demonstrate equivalency (p.325).JACIE has developed a points system to be applied in those cases where the PFD does not hold a doctoral degree but has other qualifications combined with experience. This system is described in this document (also available below this text or on request to firstname.lastname@example.org).
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