• expomed eurasia / March 14th 2022 / İstanbul / Turkey......... • Pharma & Lab Expo / May 24th 2022 / Cairo / Egypt......... • PharmaLytica / June 01st 2022 / Mumbai / India......... • Medlab Expo / Nov 07th 2022 / Riyad / Saudi Arabia.........

ACRONYMS FULL FORM
AADA Abbreviated Antibiotic Drug Application
ABHI Associated of British Healthcare Industries
ABPI Associated of the British Pharmaceutical Industry
ACTD ASEAN Common Technical Dossier
ADC Aditional Data Collection
ADI Acceptable Daily Intake
ADR Adverse Drug Reaction
AE Adverse Event
AEFI Adverse Event Following Immunisation
AIM Active Ingredient Manufacturer
AIMD Active Implantable Medical Device
ANDA Abbreviated new Drug Application
API Active Implantable medical Device
AQL Acceptable Quality Level
AR Assessment Report(European Union)
ASMF Active Substance Master File
ATMPs Advanced Therapy Medicinal Products
BA Bioavailability
BAN British Approved Name
BAP Biotechnology Action Programme
BIND Biological Investigational New Drug
BWP Biotech Working Party (EMA)
C&P Chemistry And Pharmacy
CA Commercial Appraisal
CA Competent Authority
CANDA Computer Assisted New drug Application
CAP Centrally Authorised Product
CAPA Corrective Action And Preventive Action
CAPLA Computer Assisted Product Licence Application
CC Candidate Country
CCDS Company Core Data Sheet
CCG Clinical Commissioning Group (UK)
CD Controlled Drug
CDSCO Central Drug Standard Organisation (India)
cGLP Current Good Laboratory Practice
cGMP Current Good Manufacturing Practice
CI Total Body Clearance
CLO Clinical Overview
CLS Clinical Summary
CMC Chemistry-Manufacturing-Controls
CMP Certificate Of Medicinal Product
COA Certificate of Analysis
CoFS Certificate of Free Sales
CP Centralised Procedure (European Union)
CP Comparability Protocol (USA)
CPD Continuing Professional Development
CPP Certificate of Pharmaceutical Product
CPP Critical Process Parameter
CQA Clinical Quality Assurance
CR Controlled Release
CRF Case Report Form
CRO Clinical Research Organisation
CSI Core Safety Information
CSP Core Safety Profile
CSR Clinical Study Report(European Union)
CT Clinical Trial
CTA Clinical Trial Application
CTA Clinical Trial Authorisation
CTC Clinical Trial Certificate (UK)
CTD Clinical Trial Directive
CTD Common Technical Document/Dossier
CTMS Clinical Trial Management System
CTS Common Technical Specification
CTX Clinical Trial Exemption (UK)
CVM Center For Veterinary Medicine (US)
DACS Detailed and Critical Summary
DAE Discontinuation due to an adverse event
DDD Defined Daily Dose
DDPS Detailed Description of Pharmacovigilance System
DMF Drug Master File
DMS Document management system
DOE Design of experiments
DP Drug product
DS Drug substance
DSUR Development safety update report
DTC Direct-to-consumer
DUS Drug utilisation study
EA Environmental assessment
EC Ethics committee
eCTD electronic common technical document
EDC electronic data capture
EDMF European drug master file
EDT Electronic data transfer
ENS Early notification system
EPI Essential Program for Immunisation
EPL Effective patent life
ePSUR electronic periodic safety update report
ERB Ethical review board
ESPAR Executive Summary Pharmacovigilance Assessment Report
EWG Expert Working Group
EWP Efficacy Working Party
FAR Final assessment report
FMEA Failure mode and effects analysis
FTE Full Time Equivalent
GCP Good clinical practice
GDP Good distribution practice
GGP Good guidance practice
GLP Good laboratory practice
GMP Good manufacturing practice
GMP Good management practice
GPP Good paediatric practice
GPP Good pharmacoepidemiology practice
GpvP Good pharmacovigilance practice
GRB Global Regulatory Board
GRP Good regulatory practice
GSL General sales list
GSP Good statistics practice
GVP Good pharmacovigilance practice
HCP Healthcare professional
HEOR Health economics and outcomes research
HREC Human Research Ethics Committee
HTA Health technology assessment
HTS High-throughput screening
IB Investigator’s brochure
IC Informed consent
ICD Informed consent document
ICSR Individual case safety report
IDE Investigational Device Exemption
IDMP Identification of medicinal products
IEC Independent ethics committee
IM Issue management
IME Important medical event
IMI Innovative Medicines Initiative
IMP Investigational medicinal product
IMPD Investigational medicinal product dossier
IMRDF International Medical Device Regulatory Forum
IMS Information management strategy
INDA Investigational new drug application (USA)
INDC Investigational New Drug Committee
IP Intellectual property
IPO Intellectual Property Office
IPR Intellectual property rights
IQM Integrated quality management
IRB Institutional review board
IRD International registration document
IRN Incident Review Network
IS Internal standard
ISE Integrated summary of efficacy
ISRB Integrated summary of risk benefit
ISS Integrated summary of safety
KIT Key intelligence topic
KM Knowledge management
KOL Key opinion leader
LCM Lifecycle management
LED Least Effect Dose
LLL Lifelong learning
MA Marketing authorisation
MAA Marketing authorisation application (EU)
MAH Marketing authorisation holder
MAIL Medicines Act Information Letter (UK)
MAL Medicines Act Leaflet (UK)
MDCG Medical Device Coordination Group
MDD Medical Device Directive
MDEG Medical Device Expert Group
MDLO Medical Device Liaison Officer
MDR Medical device reporting
MERS Multi-agency electronic regulatory system
MHRA Medicines and Healthcare products Regulatory Agency (UK)
ML Manufacturer’s licence (UK)
MOU Memorandum of Understanding
MRA Mutual recognition agreement
NAP Nationally authorised product
NBE New biological entity
NCE New chemical entity
NCO Non clinical overview
NCS Non clinical summary
NDAC New Drug Advisory Committee (India)
NED Non effect dose
NIMP Non-investigational medicinal product
NIMP Non-investigational medicinal product
NME New molecular entity
OD Orphan drug
ODA Orphan Drugs Act (USA)
ODD Orphan drug designation
OIA Orphan drug designation
OOS Out of specification
OPD Original pack dispensing
OTC Over-the-counter
P&R Pricing and reimbursement
P Pharmacy only
P to GSL Pharmacy to General Sales List
PA Product authorisation
PAI Pre-approval inspection
PAR Preliminary assessment report
PASS Post authorisation safety study
PAT Process analytical technology
PCT Primary care trust
PDE Personal daily exposure
PER Pharmaceutical evaluation report
PGD Patient group direction
PI Prescribing information
PI Production information
PIL Patient information leaflet
PIP Paediatric investigation plan
PMS study Post-marketing safety study
PMS Postmarket(ing) surveillance
POM Prescription-only medicine
POM to P Prescription-only medicine to pharmacy
PPI Patient and Public Involvement (UK)
PRSPH Potential serious risk to public health
PSMF Pharmacovigilance system master file
PTE Patent term extension
PUMA Paediatric-use marketing authorisation
PV Pharmacovigilance
PVAR Preliminary Variation Assessment Report
QA Quality assurance
QbD Quality by design
QC Quality control
QMS Quality management system
QOL Quality of life
QoS Quality overall summary
QP Qualified person
QPPV Qualified person for pharmacovigilance
QRD Quality review of documents [template]
RA Regulatory affairs
RCFID Registration Certificate for Import of Drug
RCT Randomised controlled trial
RDE Remote data entry
RDS Repeat dose study
RDT Rising-dose tolerance
REACH Registration, evaluation, authorisation and restriction of chemicals
RI Regulatory intelligence
RING Regulatory Intelligence Network Group
rINN Recommended international non-proprietary name
RMM Risk minimisation measure
RMP Reference medicinal product
RMR Reaction monitoring report
ROI Return on investment
RoW Rest of world
RP Responsible person
RPS Regulated product submission
Rx Prescription
S+T Sampling and testing
SAG Scientific Advisory Group
SAP Scientific advice procedure
SAWP Scientific Advice Working Party
SI Statutory instrument
SLA Service level agreement
SME Significant medical event
SMF Site master file
SMO Site management organisation
SMQ Standardised MedDRA query
SOP standard operating procedure
SPIN Special interest network
SSC Scientific Steering Committee
SWOTs Strengths – weaknesses – opportunities – threats
TAG Therapeutic Advisory Group
TLV Threshold limit value
TOC Table of contents
TOD Table of decisions
TOPRA The Organisation for Professionals in Regulatory Affairs
TPP Target product profile
VAI Voluntary action indicated
WC Written confirmation
WL Wholesale dealer’s licence
WRAC Worldwide Regulatory Affairs Committee

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