News & Media
Gli acronimi del Pharma
28 Novembre 2016
News
Pubblichiamo di seguito un primo elenco non esaustivo degli acronimi maggiormente usati nel settore farmaceutico.
Scrivi a info@pharmahub-italy.it per segnalare altri acronimi che andranno ad arricchire l’elenco pubblicato.
| TERMINI | DEFINIZIONE |
| AIC | Autorizzazione Immissione in Commercio |
| AIFA | Agenzia Italiana del Farmaco |
| API | Active Pharmaceutical Ingredients |
| CAPA | Corrective and Preventive Action |
| ASMF | Active Substance Master Files |
| CMC | Chemistry, Manufacturing, and Controls |
| CP | Centralized Procedure |
| CRC | Clinical Research Coordinator |
| CRO | Contract Research Organisation |
| CSR | Clinical Study Report |
| CTD | Common Technical Dossier |
| CTC | Clinical Trial Certificate |
| DMF | Drug Master File |
| EDC | Electronic Data Capture |
| FDA | Food and Drug Administration |
| GCP | Good Clinical Practice |
| GDP | Good Distribution Practice |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practice |
| GPvP | Good Pharmacovigilance Practise |
| GVP | Good Vigilance Practises |
| HMPC | Committee on Herbal Medicinal Products |
| ICDRA | International Conference of Drug Regulatory Authorities |
| IDE | Investigational Device Exemption |
| IFPMA | International Federation of Pharmaceutical Manufacturers & Associations |
| ISO | International Organization for Standardization |
| LoA | Letter of Access |
| MD
Metabolomics
MRFG |
Medical Device
Metabolomics is an emerging “omics” science that takes a global view of an organism – that is, it attempts to understand the current physiological status of a sample or organism in light of its full physiological potential. New!
The Mutual Recognition Facilitation Group New! |
| NB | Notified Body |
| NBF | Norme di Buona Fabbricazione |
| NDA | New Drug Application |
| NDS | New Drug Submission |
| NIH | National Institutes of Health |
| NPA | National Pharmaceutical Association |
| OD | Orphan Drug |
| PIL | Product Information Label |
| PIM | Product Information Management |
| PIP | Pediatric Investigation Plan |
| PMA
Population PK |
Pre-market Authorization for approval of class III devices
Population PK is the study of the sources and correlates of variability in drug concentrations among individuals who are the target patient population receiving clinically relevant doses of a drug of interest. New! |
| PRAC | Pharmacovigilance Risk Assessement Committee |
| PSMF | Pharmacovigilance Sistem Master File |
| PSUR | Product Safety Update Report |
| PVAR | Preliminary Variation Assesment Report |
| RMS | Reference Member State |
| SCADA
SPC |
Supervisory Control and Data Acquisition
Supplementary Protection Certificate New! |
| QA | Quality Assurance |
| QC | Quality Control |
| QOS | Quality Overall Summary |
| QP | Qualified Person |
| QPPV | Qualified Person Pharmacovigilance |
| QRD | Quality Review of Documents |
| REACH | Registration, Evaluation, Authorisation and Restriction of Chemicals |
| R&D | Research and Development |
| RMP | Risk Management Plan |
| SMF | Site Master File |
| SOP | Standard Operating Procedure |