Authorities BfArM Bundesinstitut für Arzneimittel und Medizinprodukte, DE Federal Institute for Drugs and Medical Devices, DE EC GLP European Commission's GLP page EMEA European Medicines Agency 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 MHLW Ministry of Health, Labour and Welfare, JP MHRA Medicines and Healthcare Products Regulatory Agency, UK PEI Paul-Ehrlich-Institut, Bundesamt für Sera und Impfstoffe, DE Paul-Ehrlich-Institute, Federal Agency for Sera and Vaccines, DE PERF-EUDRA Pan European Regulatory Forum (EU Enlargement) PMDA Pharmaceutical and Medical Devices Agency, JP Associations / Societies ACDM Association for Clinical Data Management ACRP Association of Clinical Research Professionals AFCROs Association Française des CROs French CRO Association AGAH Arbeitsgemeinschaft für angewandte Humanpharmakologie, DE Association for Applied Human Pharmacology, DE AHPPI Association for Human Pharmacology in the Pharmaceutical Industry, UK APV International Association for Pharmaceutical Technology ASQ American Society for Quality BARQA The Research Quality Association, UK BVMA Bundesverband Medizinischer Auftragsinstitute, DE Federal Association of Medical Contract Organizations, DE CCRA Clinical Contract Research Association, UK CEN European Committee for Standardization Club Phase I Club Phase I - Association des Professionnels du Développement Précoce des Médicaments, FR Phase I Club - Association of Professionals in Early Phase Drug Development, FR CR-CSV Joint ACDM/PSI Working Group on Computer System Validation in Clinical Research DARQA Dutch Association of Research Quality Assurance DGGF Deutsche Gesellschaft für Gute Forschungspraxis German Society for Good Research Practices DGPharMed Deutsche Gesellschaft für Pharmazeutische Medizin German Society of Pharmaceutical Medicine DGQ Deutsche Gesellschaft für Qualität German Society for Quality DIA Drug Information Association DIN Deutsches Institut für Normung German Institute for Standardisation DKG Danish Quality Assurance Group EFGCP European Forum for Good Clinical Practice EFPIA European Federation of Pharmaceutical Industries and Associations EFQM European Foundation for Quality Management EFSPI European Federation of Statisticians in the Pharmaceutical Industry EOQ European Organization for Quality EUFEPS European Federation for Pharmaceutical Sciences FQS Forschungsgemeinschaft Qualität, DE Research Community Quality, DE GIQAR Gruppo Italiano Quality Assurance nella Ricerca Italian Research Quality Assurance Society GPM Gesellschaft für Pharmazeutische Medizin, AT Society for Pharmaceutical Medicine, AT ICH International Conference on Harmonization ICR Institute of Clinical Research, UK IFAPP International Federation of Associations of Pharmaceutical Physicians IFPMA International Federation of Pharmaceutical Manufacturers Associations ISCB International Society for Clinical Biostatistics ISO International Organization for Standardization JSQA Japan Society for Quality Assurance MonCRANet Netzwerk der klinischen Monitore und CRAs, DE Network of Clinical Monitors and CRAs, DE Nuffield Bioethics Nuffield Council on Bioethics, UK OECD Organization for Economic Co-operation and Development OECD GLP Organisation for Economic Co-operation and Development (GLP) PCMG Pharmaceutical Contract Management Group PhRMA Pharmaceutical Research and Manufacturers of America, US PIC/S Pharmaceutical Inspection Convention POMA Pharmaceutical Outsourcing Management Association PSI Statisticians in the Pharmaceutical Industry 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 SoCRA Society of Clinical Research Associates SoFAQ Société Française d'Assurance de Qualité French Quality Assurance Society SQA Society of Quality Assurance, US TOPRA The Organisation for Professionals in Regulatory Affairs VKliPha Verbund Klinische Pharmakologie in Deutschland Clinical Pharmacology Network in Germany WHO World Health Organization WMA World Medical Association Useful Links 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 MedDRA Medical Dictionary for Regulatory Activities