xxx gli acronimi del pharma

Gli acronimi del Pharma

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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

 

 

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