Committee for the management of EuroGTP II project’s Outcomes
General Information
Identification Code: 947358741140-13
Website: [object Object]
Entity Form: no specific legal status (temporary set-up)
Registration Category: Trade unions and professional associations
Registration Date: 1/29/2021
Last Update: 2/26/2024
EP Accredited Number: 0
Mission & Interests
Goals: The extensive collaboration and consultation with the scientific societies during the EuroGTP II project revealed the importance of the endorsement of good practices by these organisations, as stakeholders rely on the scientific and technical knowledge of experts to comply with the best practices according the state-of-the-art standards and tools.
The main goal of the EuroGTP II Management Committee is to ensure the appropriate representation of experts in the future management of tools and development of methodologies.
Interests Represented: Promotes their own interests or the collective interests of their members
Interests:
- Public health
- Research and innovation
- Trans-European Networks
Levels of Interest:
- european
Activities
Main EU Legislative Proposals: Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC Commission Directive 2006/17/EC regarding certain technical requirements for the donation, procurement and testing of human tissues and cells
Commission Directive 2006/86/EC concerning traceability requirements, notification of serious adverse reactions and events, additional technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
Commission Directive 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
Commission Directive 2015/566 implementing Directive 2004/23/EC concerns the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.
Communication Activities: The EuroGTP II Management Committee plans to interact with DG Health and Food Safety to influence the definition of the best practices and legal requirements to be included in the European Tissue, Cells and Blood Directives (EUBTCD).
Our aim is to influence the definition of legal procedures associated with the authorisation and evaluation of Tissue and Blood Establishments activities in the European Union, by incorporating the practices defined by:
- GAPP ((facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) - 785269 — GAPP — HP-JA-2016-2), and
- EuroGTP II EuroGTP II Project (http://goodtissuepractices.eu/) - Good Practices for evaluating quality, safety and efficacy of novel tissue and cellular therapies and product - 709567
The publications associated with the EuroGTP II project are evidences of the impact of the practices proposed to assess the quality and safety of Substances of Human Origin (SoHO), which should be considered for the current revision of EUBTCD:
1. EuroGTP II: a tool to assess risk, safety and efficacy of substances of human origin. International Journal for Quality in Health Care, 2019, 1–5 doi: 10.1093/intqhc/mzz048
2. EuroGTP II Study Group. Evaluating risk, safety and efficacy of novel reproductive techniques and therapies through the EuroGTP II risk assessment tool. 2020. Hum Reprod 1;35(8):1821-1838. doi: 10.1093/humrep/deaa146.
3. Banking of corneal stromal lenticules: a risk-analysis assessment with the EuroGTP II interactive tool. Cell and Tissue Banking. 2020. DOI 10.1007/s10561-020-09813-8
4.Quality by Design: Development of Safe and Efficacious Full-Thickness Acellular Dermal Matrix Based on EuroGTPII Methodologieson. López-Chicón P, Pérez ML, Castells-Sala C, Piteira AR, Fariñas O, Tabera J, Vilarrodona A.
C Ther Clin Risk Manag. 2023;19:567-578. https://doi.org/10.2147/TCRM.S410574
Moreover, the members of the EuroGTP II Management Committee actively collaborate with the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, in the definition of technical requirements which are intended to be included in the regulation as part of the revised EUBTCD.
Inter-institutional or Unofficial Groupings: N/A
Head Office
Address: Passeig Taullat 116
Post Code: 08005
City: Barcelona
Country: SPAIN
Phone: [object Object]
EU Office
Address: Passeig Taullat 116
Post Code: 08005
City: Barcelona
Country: SPAIN
Phone: [object Object]
Financial Data
New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]
Membership Information
Members10 Percent: 4
Members25 Percent: 0
Members50 Percent: 0
Members75 Percent: 0
Members: 4
Members F T E: 0.4000000059604645
Structure
Structure Type: Structure
Is Member Of: http://goodtissuepractices.eu/
Organisation Members: (1) European Association of Tissue and Cells Banking
(2) European Eye Bank Association
(3) European Society for Blood and Marrow Transplantation
(4) European Society of Human Reproduction and Embryology
(5) Banc de Sang i Teixits - Barcelona Tissue Bank
(6) National Health Service Blood and Transplant