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Glossar und Links

ART Assisted reproduction technique
BfArM Bundesinstitut für Arzneimittel und Medizinprodukte
CDER (FDA) Center of Drug Evaluation and Research
CER Clinical export report
COPD Chronic obstructive pulmonary disease
COS Controlled ovarian stimulation
CPMP Committee for Proprietary Medicinal Products
CRF Case report form
CRO Contract research organisation
CTD Common technical document (ICH)
CTX Clinical Trial Exemption
DGPharMed Deutsche Gesellschaft für Pharmazeutische Medizin www.dgpharmed.de
ECPM European Center of Pharmaceutical Medicine www.ecpm.ch
eCTD Electronic common technical document
EMA European Medicinal Agency (formerly: EMEA) www.emea.eu.int
EMWA European Medical Writers Association www.emwa.org
EUCOR Europäische Conföderation der oberrheinischen Universitäten (Basel, Freiburg, Strasbourg) www.eucor-uni.org
FDA Food and Drug Administration (USA) www.fda.gov
GCP Good clinical practice
IB Investigator's brochure
ICH International conference of harmonisation (of technical requirements for registration of pharmaceuticals for human use) www.ich.org
IND Investigational new drug (application)
ISE Integrated Summary of Efficacy
ISS Integrated Summary of Safety
MAA Marketing authorisation application (UK)
MCA Medicines Control Agency (UK)
NDA New drug application (US)
SOP Standard operating procedure
SwAPP Swiss Association of Pharmaceutical Professionals www.swapp.ch