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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
ECPM European Center of Pharmaceutical Medicine
eCTD Electronic common technical document
EMA European Medicines Agency
EMWA European Medical Writers Association
EUCOR Europäische Conföderation der oberrheinischen Universitäten (Basel, Freiburg, Strasbourg)
FDA Food and Drug Administration (USA)
GCP Good clinical practice
IB Investigator's brochure
ICH International Council on Harmonisation (of technical requirements for registration of pharmaceuticals for human use)
IND Investigational new drug (application)
ISE Integrated Summary of Efficacy
ISS Integrated Summary of Safety
MAA Marketing authorisation application
MHRA Medicines and Health Products Regulatory Agency (UK)
NDA New drug application (US)
NIS Non-interventional study
SOP Standard operating procedure
SwAPP Swiss Association of Pharmaceutical Professionals