Irish Medicines Board
The fundamental role of the Irish Medicines Board is to protect and enhance
public and animal health through the regulation of medicines, medical devices and healthcare products.
Irish Medicines Board
The fundamental role of the Irish Medicines Board is to protect and enhance
public and animal health through the regulation of medicines, medical devices and healthcare products.
EU Legal Documents RE: Tissues and Cells
EUROPA is the portal site of the European Union (
http://europa.eu). It provides up-to-date
coverage of European Union affairs and essential information on European integration. Users can
also consult all legislation currently in force or under discussion, access the websites of
each of the EU institutions and find out about the policies administered by the European Union
under the powers devolved to it by the Treaties.
FDA - 21 CFR Part 1271 Good Tissue Practice
Through specially targeted initiatives, the FDA intensifies efforts to ensure the safety of
America's food supply, and to make safe, effective, and affordable medical products available
to the public, whether imported or made in the USA.
21 CFR Part 1271 deals with human cells,
tissues, and cellular and tissue-based products.
FDA Q & A Bar Code Label Requirements (htm)
Through specially targeted initiatives, the FDA intensifies efforts to ensure the safety of
America's food supply, and to make safe, effective, and affordable medical products available
to the public, whether imported or made in the USA.
This page lists common questions and answers concerning bar code label requirements for human
drug products and biological products.
FDA Bar Code Label Requirements (pdf)
Through specially targeted initiatives, the FDA intensifies efforts to ensure the safety of
America's food supply, and to make safe, effective, and affordable medical products available
to the public, whether imported or made in the USA.
This pdf document details bar code label requirements for human drug products and biological products.
ISBER
The primary goal of the International Society for Biological and Environmental Repositories,
ISBER, is to provide information and guidance on the safe and effective management of specimen collections.
ISBER was founded in 2000 as an educational forum for discussion of repository management and dissemination
of information on operational issues. The society serves to pool and share collective knowledge
and experiences with colleagues. This knowledge helps member repositories operate more efficiently
in managing and preserving their collections. Careful management ensures the collections are available
for study as new biomarkers emerge and more sensitive measurement technologies become pertinent.
JACIE Standards
The Joint Accreditation Committee-ISCT & EBMT is a non-profit body established in 1998 for the purposes
of assessment and accreditation in the field of haematopoietic stem cell (HSC) transplantation. JACIE's
primary aim is to promote high quality patient care and laboratory performance in haematopoietic stem
cell collection, processing and transplantation centres through an internationally recognised system
of accreditation.
CEN European Committee for Standardisation
The 'Tissues and cells' Directive, 2004/23/EC of the European Parliament and of the Council, sets
standards of quality and safety for the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells.
Under Article 25 of the Directive, the Member States have the obligation to establish a coding
system for the identification of human tissues and cells, in order to ensure their traceability.
The Commission is also required to design a single European coding system to provide information on the
main characteristics and properties of tissues and cells. Commission Directive 2006/86/EC implementing
Directive 2004/23/EC in respect of several provisions, including traceability and coding, sets 1 September
2008 as the date for having an operational single coding system in place.
ISBT 128
ISBT 128 sets a global standard for the identification, labeling and information processing of human blood,
tissue and organ products across international borders and disparate health care systems. The standard has
been designed to ensure the highest levels of accuracy, safety and efficiency for the benefit of donors,
patients and official ISBT 128 licensed facilities worldwide.
Featuring a unique, highly flexible and comprehensive coding method for every collected product,
ISBT 128 provides international consistency to support the transfer, transfusion or transplantation of
blood and tissue products.
Ann McGee Consulting
Ann McGee Consulting offers consultancy services to the pharmaceutical industry, to health regulatory and government bodies,
to hospital and community pharmacies and to the allied healthcare arena that are involved in the development,
manufacture, distribution, sale or supply of medicinal products.
E Fitzmaurice & Associates
E Fitzmaurice & Associates was formed to provide support and consultancy in the following areas :
Quality Systems, Documentation, Vendor Management, Microbiology, New Product Introduction and
Technical Transfer Training.
Wexford County Enterprise Board
Wexford County Enterprise Board offers financial assistance (i.e grant aid) and non-financial assistance
(i.e. training, mentoring, management development, advice and information ) to both start up businesses
and existing small businesses in County Wexford, Ireland.
Wexford County Enterprise Board is one of 35
Enterprise Boards established by the Irish government to assist the development of an enterprise culture
and to support small business (i.e businesses with less than 10 employees). Wexford County Enterprise Board
also promotes entrepreneurship in primary and secondary schools through enterprise competitions.
Enterprise Ireland
"We are the Irish state development agency focused on transforming Irish industry.
Our core mission is to accelerate the development of world-class Irish companies to achieve strong positions
in global markets resulting in increased national and regional prosperity.
Through our extensive network
of 13 Irish offices and 32 international offices, we work with our clients to assist them to compete
and to grow. Our focus, for Irish companies, is on five main areas of activity: Achieving export sales;
investing in research and innovation; competing through productivity; starting up & scaling up and
driving regional enterprise. We also provide assistance for international companies who are searching
for world-class Irish suppliers and we can help international companies who want to set up food and
drink manufacturing operations in Ireland."
South East Business & Innovation Centre
The South East Business & Innovation Centre Ltd (South East BIC) was established to assist the
development of innovative enterprise in the South East Region of Ireland, covering counties Waterford,
Wxford, Kilkenny, Carlow and Tipperary SR. It is part-funded under the National Development
Plan 2007-2014 and supported by a range of regional organisations from industry, higher education and
the public sector.
"We provide support to entrepreneurs and existing companies
at every stage of a project's development, from start-up support with incubation office space,
feasibility studies and business planning, through to expansion of your existing business into
new markets or new product development."
Baku GLS Ltd.
- Formed in 2000
- Professional Logistics Services to Irish industry
- Logistics Providers to the Pharmaceutical / Healthcare sectors
- Irish Medical Board Approved Facilities
- Road Transport Services throughout Europe and the Accession States
- Cryogenic and Cold Storage to -196 degrees celsius. IMB Approved
- Storage of Finished Product
MTS Cryo Stores
MTS Cryo Stores are an accredited off site sample storage facility, storing specimens for universities,
government, biotechnology and pharmaceutical companies. We are an original European company based in
the heart of the UK. The personal touch of our dedicated and enthusiastic team makes us a popular choice
for biobanking services. Our facility can store up to 2 million samples at temperatures ranging from
ambient to -150°C in mechanical refrigeration units, with -196°C Liquid Nitrogen (LN2) cryogenic storage
also available. We operate under HTA licence 22499.
Biobank Ireland Trust
Biobank Ireland is promoting the development of a Hospital Biobank Network throughout the island
of Ireland as a bridge between cancer research and care.
Biobank Ireland was founded 3 years ago by Professor Eoin Gaffney (St James's Hospital and Trinty
College Dublin) and Ciaran Flanagan, managing director of marketing firm IDEA. CF wanted to obtain
business/philanthropic support for medical research. Irish research infrastructure needed improvement
and biobanking was beginning to be recognised as essential for large scale research studies. It was
therefore agreed to promote a Biobank Network for Ireland.
Designs.ie ]