Resources
This section lists information resources which provide background information for the workshop, including, in particular, documents and hyperlinks to materials from organizations actively involved in standardization initiatives covering a plurality of biotechnology fields.
Summary of the ISO Council Task force recommendations
(September 2009)
Webinar 14 June 2011
- Annex 3 [PDF, 252kB]: Dr. Norbert Gerbsch PPT
- Annex 3.1 [PDF 66kB]: Written comment from Dr. Tomoshige Hori
- Annex 4 [PDF, 130kB]: Summary of the Webinar (morning and afternoon sessions)
Webinar 5 July 2011
- Annex 5 [PDF, 245kB]: Dr. Jane Morris PPT
- Annex 6 [PDF, 2261kB]: Dr. Susanna Sansone PPT
- Annex 7 [PDF, 1014kB]: Dr. Marc Salit PPT
- Annex 8 [PDF, 139kB]: Summary of the Webinar (morning and afternoon sessions)
Organizations
Selected relevant ISO Technical bodies and documents
ASTM – Biotechnology Standards for Industrial-Enviro Applications
Home page: http://www.astm.org
BIO – Biotechnology Industry Organization
Home page: http://www.bio.org/
Biosharing
Home page: http://www.biosharing.org
BioSharing is a collaborative project:
- partnership with BioMedCentral, open access publisher: http://blogs.openaccesscentral.com/blogs/bmcblog/entry/
bmc_research_notes_and_biosharing - collaboration with Nature Genetics/Precedings, see editorial: http://www.nature.com/ng/journal/v43/n6/full/ng.853.html
BioSharing’s origin:
- stems from the initial work published in collaboration with a range of representatives from US, UK and European funding agencies; Science – Policy Forum “Omics” data sharing: http://www.ncbi.nlm.nih.gov/pubmed/19815759
- extends the work of MIBBI (Minimum Information for Biological and Biomedical Investigations): http://mibbi.org
BIPM – International Bureau of Weights and Measures
BIPM’s home page: http://www.bipm.org/en/home/
Study of Measurement Service and Comparison Needs for an International Measurement Infrastructure for Biosciences and Biotechnology: Input for the BIPM Work Programme’:
http://www.bipm.org/en/scientific/chem/biostudy_report.html
http://www.bipm.org/utils/common/pdf/rapportBIPM/2011/02.pdf
Joint Committee for Guides in Metrology: http://www.bipm.org/en/committees/jc/jcgm/
BSI – British Standards Institute
Home page: http://www.bsigroup.com
- Annex 13 [PDF, 888kB]: Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics
- Annex 14 [PDF, 432kB]: Regenerative medicine – Glossary
CEN / NEN (Netherlands Standardization Institute)
CEN home page: www.cen.eu
NEN home page: www.nen.nl
CWA 15793:2008 (Management system for laboratory biosafety and biosecurity)
CEN Workshop Agreement (CWA) 15793 sets requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.
CWA 15793 is available to the public for free.
More information is given in the Workshop's business plan.
CWA 16335:2011 (Competence of a BioSafety Professional (BSP))
CEN Workshop Agreement (CWA) 16335 addresses the broad range of competences and abilities required by individuals who advise management and personnel on the safe and secure use of biological material and who manage and support the development and implementation of relevant management programmes or systems.
While this CWA is primarily intended for biosafety professionals, it will also be of interest for employers (managers) and trainers.
It was developed in response to identified needs across the international community, informed by the experience of practitioners through professional organizations and WHO.
More information is given in the Workshop's business plan.
CWA 163xx:2011 (describing guidance on the use and implementation of CWA 15793:2008, to be published by the end of 2011)
Following the release of CWA 15793 and its distribution worldwide, the user community (laboratories, managers, biosafety and biosecurity professionals and others) identified the need for an additional document assisting in the understanding of the CWA 15793 and helping end-users in the actual implementation. This CWA provides informative guidance to aid the interpretation of CWA 15793 on biorisk management.
More information is given in the Workshop's business plan.
Europabio – European Association for Bioindustries
Home page: http://www.europabio.org/
FDA Microarray/Sequencing Quality Control activities
Home page: http://www.fda.gov/ScienceResearch/BioinformaticsTools/
MicroarrayQualityControlProject/default.htm
FGED – Functional Genomics Data Society
Home page: http://www.fged.org/
GSC – Genomic Standards Consortium
Home page: http://gensc.org/gc_wiki/index.php/Main_Page
GSC 12th Workshop (28-30 September 2011): http://gensc.org/gc_wiki/index.php/GSC_12
Health Level 7 (HL7) – Clinical Genomics Committee
Home page: http://www.hl7.org/special/Committees/clingenomics/
Investigation, Study, Assay (ISA) framework
An example of a collaboratively built open-source system that facilitates standards-compliant collection, care, management, distribution and re-use of bio-investigations
Home page: http://www.isa-tools.org
JBA – Japan Bioindustry Association
Home page: http://www.jba.or.jp/english/
OECD (Organisation for Economic Co-operation and Development) – Biotechnology policies
http://www.oecd.org/department/0,3355,en_2649_34537_1_1_1_1_1,00.html
The Open Biological and Biomedical Ontologies (OBO Foundry)
Home page: http://www.obofoundry.org/
The Ontology for Biomedical Investigations (OBI)
An example of a collaboratively built ontology, that illustrates the concept of synergizing as a way to build and maintain a common terminology across different bio-community.
Home page: http://obi-ontology.org/page/Main_Page
Pistoia Alliance
Home page: http://www.pistoiaalliance.org
PSI – HUPO Proteomic standards initiative
Home page: http://www.psidev.info/
STRENDA
STRENDA is a Commission created by the Beilstein-Institut. The name represents Standards for Reporting Enzymology Data.
Home page: http://www.beilstein-institut.de/en/projects/strenda/
Selected publications that describe best the objectives and projects of STRENDA:
5th ESCEC Symposium (12-16 September 2011) :
W3C Semantic Web Health Care and Life Sciences (HCLS) Interest Group
Home page: http://www.w3.org/2001/sw/hcls/