EBMT NEWSLETTER | June 2017 | Volume 57 - Issue 3

Important dates

7th edition FACT-JACIE Standards
JACIE Training Course
Public consultation launched on EU blood, tissues and cells legislation
The first FACT-JACIE Accreditation Workshop
Survey on Advanced Therapy Medicinal Products (ATMP)

7th edition FACT-JACIE Standards

Draft version open for public consultation

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) have published the draft 7th edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment for a 90-day period.

Comments will be accepted from May 1, 2017 through July 30, 2017.

More information at http://www.jacie.org/news/draft7theditionfact-jaciestandardsavailableforpubliccomment

JACIE Training Course

1-2 June 2017 in Barcelona, Spain

21 participants from 9 countries attended the JACIE Training Course in early June.

The next course is on 5-6 October in Barcelona and registration will open shortly.
We will also hold an event in Warsaw on 23-24 November – more information to come shortly.

Public consultation launched on EU blood, tissues and cells legislation

The Commission seeks to gather views on the extent to which the 2002 Directive setting standards of quality and safety for human blood and the 2004 Directive setting standards for human tissues and cells, have met their original objectives and whether they remain fit for purpose. The consultation of citizens and stakeholders, launched today, will run until the end of August 2017. Interested parties are invited to participate online.

The EBMT will respond to the consultation as a society and in collaboration with similar organisations but individuals and organisations are strongly encouraged to participate. Remember that this legislation impacts on the day-to-day activities in cell collection and cell processing facilities so your voice is important.

More information at https://ec.europa.eu/health/blood_tissues_organs/consultations/implementation_legislation_en

The first FACT-JACIE Accreditation Workshop

17 May 2017 in Buenos Aires, Argentina

The first FACT-JACIE Accreditation Workshop was the result of close collaboration between JACIE, FACT, and the Latin American Group for Blood and Marrow Transplantation (LABMT), and took place one day before the first Argentine Transplantation Congress and second LABMT congresses.

More information http://www.jacie.org/news/fact-jacieinternationalinspectionandaccreditationworkshopbuenosaires

Survey on Advanced Therapy Medicinal Products (ATMP)

Help improve product development and regulation

Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle.

Note: EBMT is not a contributor to this survey and it appears here for information purposes.

More information at http://www.lygature.org/escher#Final-call-ATMP-survey-Help-improve-product-development-and-regulation

Response deadline: 30 June
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