| 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 |
|
