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Common representation of Substances of Human Origin’s (SoHO)

Acronym: CoRe SoHO

General Information

Identification Code: 643638449840-70
Entity Form: None
Registration Category: Other organisations, public or mixed entities
Registration Date: 4/17/2023
Last Update: 4/22/2024
EP Accredited Number: 0

Mission & Interests

Goals: The main goal of this consortium is to provide representative technical expertise to the European decision making organizations in the field of SoHO. In particular, the aforementioned Associations would wish to be formally represented in official consultation forums so as to provide technical information to be used in drafting of new legislation and revising existing legislation. The information will be gathered by surveying technical experts working in the field among our members, including but not limited to tissue establishments, academic GMP-facilities and technical experts. This common representation identified the main activities and goals: - Promote ethical principles (non-financial gain, voluntary and altruistic donation) by demonstrating their impact for the quality and safety of T&C; - Sponsor the high value of SoHO’s therapies; - Promote the safety and quality and the development of new therapies; - Provide technical inputs to the drafting of directives (...)
Interests Represented: Promotes their own interests or the collective interests of their members
Interests:
  • Public health
Levels of Interest:
  • european

Activities

Main EU Legislative Proposals: Main EU legislative proposals or policies targeted: The need for representation of stakeholders in the European decision making organisations was identified by 4 Scientific Associations: - European Association of Tissue and Cell Banks (EATCB); - European Society for Blood and Marrow Transplantation (EBMT); - European Eye Bank Association (EEBA); - European Blood Alliance (EBA). All 4 Associations are committed to ensuring that substances of human origin (SoHO) activities at EU level are governed by the same principles of: - Not-for-profit/non-financial gain; - Voluntary and altruistic donation; - Sufficiency - Cost efficiency / Patient Accessibility to health care Legislative References: Commission Directive 2012/39/EU of 26 November 2012 - amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells; Commission Directive (EU) 2015/565 of 8 April 2015 - amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells; Commission Directive (EU) 2015/566 of 8 April 2015 - implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells; Regulation (EC) 1394/2007 of the European Parliament and of the Council of 13 November 2007 - on Advanced Therapy Medicinal Products (ATMP) and amending directive 2001/83/EC and regulation (EC) 726/2004 Commission Directive 2006/86/EC of 24 October 2006 – implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells; Commission Directive 2006/17/EC of 8 February 2006 – implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells; Commission Directive 2004/23/EC of 31 march 2004 - on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells; Commission Directive 2003/63/EC of 25 June 2003 - amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;
Inter-institutional or Unofficial Groupings: N/A

Head Office

Address: EBMT Executive OfficeEdifici Dr. Frederic Duran i Jordà
Post Code: 08005
City: Barcelona
Country: SPAIN
Phone: [object Object]

EU Office

Address: EBMT Executive OfficeEdifici Dr. Frederic Duran i Jordà
Post Code: 08005
City: Barcelona
Country: SPAIN
Phone: [object Object]

Financial Data

New Organisation: true
Current Year: [object Object]
Complementary Information: Please note that CoRe SoHO has no staff / office. The support for the coalition is managed through the member associations.

Membership Information

Members10 Percent: 0
Members25 Percent: 1
Members50 Percent: 0
Members75 Percent: 0
Members: 1
Members F T E: 0.25
Info Members: CORE SoHO has no employees. Support is provided by staff from the member organisations.

Structure

Structure Type: Structure
Is Member Of: European Association of Tissue AND cELL Banks (EATCB); - European Society for Blood and Marrow Transplantation (EBMT); - European Eye Bank Association (EEBA); - European Blood Alliance (EBA).
Organisation Members: European Association of Tissue AND cELL Banks (EATCB); - European Society for Blood and Marrow Transplantation (EBMT); - European Eye Bank Association (EEBA); - European Blood Alliance (EBA).