Links International

Authorities
Societies/Organizations
Useful

Authority	Link
AFSSAPS	Agence Française de Sécurité Sanitaire des Produits de Santé
AGEMED	Agencia Española de Medicamentos y Productos Sanitarios
ANM	Misiunea Agentiei Nationale a Medicamentului (National Medicines Agency), RO
ANVISA	Assessoria de Imprensa da Agência Nacional de Vigilância Sanitária, BR
BBA	Biologische Bundesanstalt für Land- und Forstwirtschaft, DE
BDA	Bulgarian Drug Agency
BfArM	Bundesinstitut für Arzneimittel und Medizinprodukte, DE
BfR/BGVV	Bundesinstitut für Risikobewertung, DE
BLAC	Bund/Länder-Arbeitsgemeinschaft Chemikaliensicherheit, DE
BMGF	Bundesministerium für Gesundheit und Frauen, AT
CBG-MEB	College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board), NL
DGG	Directoraat-generaal Bescherming van de Volksgezondheit: Geneesmiddelen (Generaldirektion Gesundheitsschutz: Arzneimittel), BE
DKMA	Lægemiddel Styrelsen (Danish Medicines Agency), DK
EC GLP	European Commission's GLP page
EMEA	European Agency for the Evaluation of Medicinal Products
EOF	Åèíéêüò Ïñãáíéóìüò ÖáñìÜêùí (National Organization for Medicines), GR
EPA	Environmental Protection Agency, US
Europa	EU Commission
FDA	Food and Drug Administration, US
FDA CBER	FDA Center for Biologics Evaluation and Research, US
FDA CDER	FDA Center for Drug Evaluation and Research, US
FDA CDRH	FDA Center for Devices and Radiologic Health, US
HPFB	Health Canada (Health Products and Food Branch)
IMB	Irish Medicines Board
IMCA	Lyfjastofnun (Icelandic Medicines Control Agency)
INFARMED	Instituto Nacional da Farmácia e do Medicamento (National Pharmacy and Medicines Institute), PT
IRMM	Institute for Reference Materials and Measurements, EU
LLV	Liechtensteinische Landesverwaltung
METI	Ministry of Economy, Trade and Industry, JP
MHLW	Ministry of Health, Labour and Welfare, JP
MHRA	Medicines and Healthcare Products Regulatory Agency, UK
Ministère de la Santé	Ministère de la Santé (Ministry of Health), LU
Ministero della Salute	Ministero della Salute (Ministry of Health), IT
MPA	Läkemedelsverket (Medical Products Agency), SE
MRU	Läkemedelsverket (Medical Products Agency), SE
MZ	Ministrstvo za zdravje Republike Slovenije (Agency for Medicinal Products), SI
NAM	Lääkelaitos Läkemedelsverket (National Agency for Medicines), FI
NIHS	National Institute of Health Sciences, JP
NMA	Statens Legemiddelverk (Norwegian Medicines Agency)
OGYI	Országos Gyógyszerészeti Intézet (National Institute of Pharmacy), HU
PEI	Paul-Ehrlich-Institut, DE
PERF-EUDRA	Pan European Regulatory Forum (EU Enlargement)
PMDA	Pharmaceutical and Medical Devices Agency, JP
RKI	Robert-Koch-Institut, DE
SAM	Ravimiamet (State Agency of Medicines), EE
SUKL	Státní Ústav Pro Kontrolu Léèiv (State Institute for Drug Control), CZ
SUKL	Štátny ústav pre kontrolu lieèiv (State Institute for Drug Control), SK
TGA	Therapeutic Good Administration, AU
UBA	Umweltbundesamt, DE
VVKT	Valstybinë Vaistø Kontrolës Tarnyba (State Medicines Control Agency), LT
VZA	Valsts Zāļu Ağentūra (State Agency of Medicines), LV
WAW	Drug Institute, PL

Society/Organization	Link
AACC	American Association for Clinical Chemistry
ACDM	Association for Clinical Data Management
ACRP	Association of Clinical Research Professionals
AFCROs	Association Française des CROs
AFQM	Austrian Foundation for Quality Management
AGAH	Arbeitsgemeinschaft für angewandte Humanpharmakologie, DE
AHPPI	Association for Human Pharmacology in the Pharmaceutical Industry, UK
APV	International Association for Pharmaceutical Technology
ASQ	American Society for Quality
BAH	Bundesverband der Arzneimittel-Hersteller, DE
BARQA	The Research Quality Association, UK
BPI	Bundesverband der Pharmazeutischen Industrie, DE
BVMA	Bundesverband Medizinischer Auftragsinstitute, DE
CAREB	Canadian Association of Research Ethics Boards
CCRA	Clinical Contract Research Association, UK
Cefic	European Chemical Industry Council
CEN	European Committee for Standardization
CEOC	European Confederation of Organisations for Testing, Inspection, Certification and Prevention
CITAC	Co-Operation on International Traceability in Analytical Chemistry
CITAC	Club Phase I - Association des Professionnels du Développement Précoce des Médicaments, FR
CPC	Clinical Providers Consortium
CR-CSV	Joint ACDM/PSI Working Group on Computer System Validation in Clinical Research
DADM	Dansk Forening for Data Management (Danish Data Management Society)
DARQA	Dutch Association of Research Quality Assurance
DECHEMA	Gesellschaft für Chemische Technik und Biotechnologie, DE
DGGF	Deutsche Gesellschaft für Gute Forschungspraxis e.V., DE
DGPharMed	Deutsche Gesellschaft für Pharmazeutische Medizin
DGQ	Deutsche Gesellschaft für Qualität
DIA	Drug Information Association
DIN	Deutsches Institut für Normung
DKG	Danish Quality Assurance Group
DMB	Data Management Biomédical, FR
DVMD	Deutscher Verband Medizinischer Dokumentare
DVTA	Deutscher Verband Technischer Assistentinnen/Assistenten in der Medizin
EC4	European Communities Confederation of Clinical Chemistry and Laboratory Medicine
EFB	European Federation of Biotechnology
EFGCP	European Federation of Biotechnology
EFPIA	European Federation of Pharmaceutical Industries and Associations
EFQM	European Federation of Pharmaceutical Industries and Associations
EFSPI	European Federation of Statisticians in the Pharmaceutical Industry
EOQ	European Organization for Quality
EOTC	European Organisation for Conformity Assessment
EPTIS	European Proficiency Testing Information System
EQALM	European Committee for External Quality Assurance Programmes in Laboratory Medicine
EUFEPS	European Federation for Pharmaceutical Sciences
Eurachem	Network Organisation for Analytical Chemistry in Europe
Eurolab	European Federation of National Associations of Measurement, Testing and Analytical Laboratories
EuropaBio	The European Association for Bioindustries
FELASA	Federation of European Laboratory Animal Science Associations
FQS	Forschungsgemeinschaft Qualität, DE
GDCh	Gesellschaft Deutscher Chemiker
GIQAR	Gruppo Italiano Quality Assurance nella Ricerca
GMDS	Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie
GPM	Gesellschaft für Pharmazeutische Medizin, AT
IAF	International Accreditation Forum
ICCA	International Council of Chemical Associations
ICH	International Conference on Harmonization
ICLAS	International Conference on Harmonization
ICR	Institute of Clinical Research, UK
IFAH	International Federation for Animal Health
IFAPP	International Federation of Associations of Pharmaceutical Physicians
IFBLS	International Federation of Associations of Pharmaceutical Physicians
IFCC	International Federation of Associations of Pharmaceutical Physicians
IFPMA	International Federation of Pharmaceutical Manufacturers Associations
ILAC	International Laboratory Accreditation Cooperation
ILSI	International Life Sciences Institute
ISCB	International Society for Clinical Biostatistics
ISO	International Organization for Standardization
ISPE	International Society for Pharmaceutical Engineering
ISRTP	International Society of Regulatory Toxicology and Pharmacology
IUPAC	International Union of Pure and Applied Chemistry
JCROA	Japanese CRO Association
JSQA	Japan Society for Quality Assurance
MonCRANet	Netzwerk der klinischen Monitore und CRAs, DE
NABR	National Association for Biomedical Research, US
NCDM	Nordic Clinical Data Management
Nuffield Bioethics	Nuffield Council on Bioethics
OECD	Organization for Economic Co-operation and Development
OECD GLP	Organisation for Economic Co-operation and Development (GLP)
PCMG	Pharmaceutical Contract Management Group
PDA	International Association for Pharmaceutical Science and Technology
PhRMA	Pharmaceutical Research and Manufacturers of America, US
PIC/S	Pharmaceutical Inspection Convention
POMA	Pharmaceutical Outsourcing Management Association
PRIM&R	Public Responsibility in Medicine and Research, US
PSI	Statisticians in the Pharmaceutical Industry
Quality Austria	Dachmarke von ÖQS, ÖVQ, ÖQA und AFQM
RAPS	Regulatory Affairs Professionals Society
SARQA	Swedish Association of Research Quality Assurance
SCDM	Society of Clinical Data Management
SCT	Society for Clinical Trials
SEGCIB	Sociedad Española de Garantía de Calidad en Investigación (Spanish Society of Research Quality Assurance)
SETAC	Society of Environmental Toxicology and Chemistry
SFSTP	Société Française des Sciences et Techniques Pharmaceutiques
SoCRA	Society of Clinical Research Associates
SoFAQ	Société Française d'Assurance de Qualité
SOT	Society of Toxicology, US
SQA	Society of Quality Assurance, US
SRA	Society of Research Administrators International
TOPRA	The Organisation for Professionals in Regulatory Affairs
VKliPha	Verbund Klinische Pharmakologie in Deutschland
WHO	World Health Organization
WMA	World Medical Association
ÖQA	Österreichische Arbeitsgemeinschaft zur Förderung der Qualität
ÖQS	Österreichische Vereinigung zur Zertifizierung von Qualitätsmanagementsystemen
ÖVQ	Österreichische Vereinigung für Qualitätssicherung

	Link
21 CFR Part 11	Resource on 21 CFR Part 11
CDISC	Clinical Data Interchange Standards Consortium
CIOMS	Council for International Organizations of Medical Sciences
EDCTP	European & Developing Countries Clinical Trials Partnership
EGE	European Group on Ethics in Science and New Technologies to the European Commission
GAMP Forum	Good Automated Manufacturing Practice Forum
ISO Country Codes	ISO 3166 Country Names and Code Elements
KKS	Koordinierungszentren für Klinische Studien, DE
MedDRA	Medical Dictionary for Regulatory Activities