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Organisations and Government Bodies

ACDM
Association for Clinical Data Management
www.acdm.org.uk

AlteCopia
Chinese Pharmaceutical Industry
www.altecopia.com

BSI
The British Standards Institution website - BS/ISO standards, quality systems assessment & certification, product testing, training, standards development, search
www.bsi-global.com

EMA
The European Agency for the Evaluation of Medicinal Products website - Publications, templates, forum; human medicines, veterinary medicines; search
www.emea.europa.eu

FDA
(US) Food and Drug Administration home-page - Links to FDA human drugs, biologics, animal drugs, medical devices/ radiological health, field operations, regulations, toxicology, safety, etc. websites; FAQs; information for consumers, industry, health professionals, patients, state & officials, women, kids
www.fda.gov

German Society for Good Research Practice
This site has British text and is a useful source
www.dggf.de

ISO
International Organisation for Standardisation website - About ISO, ISO 9000 and ISO 14000, technical work, contacts, catalogue, world standards services network
www.iso.org

JSQA
Japan Society of Quality Assurance
www.jsqa.com

NIH ClinRegs
National Institute of Allergy and Infectious Diseases
www.nihclinregs

OECD
OECD Environmental Health and Safety
www.oecd.org

Pharmaceutical Quality Grou (PQG)
The Home Page of the Pharmaceutical Quality Group - Membership, monographs, ISO 9000, meetings, links
www.pqg.org

PRCSQA
The (American) Pacific Regional Chapter of the Society of Quality Assurance - Archive, links, newsletter, meetings
www.prcsqa.org

RAPS
The Regulatory Affairs Professionals Society website - Education, resource center, publications
www.raps.org

SAG
Scientific Archivists Group
www.sagroup.org.uk

TOPRA
The Organisation for Professionals in Regulatory Affairs
www.topra.org

UK Accreditation Service (UKAS)
The United Kindom Accreditation Service
www.ukas.com

21CFRPart11.com
Our goal is to provide a website where people can access information on the rule and actively discuss issues and concerns with industry peers and government regulators.
www.21cfrpart11.com

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