A | |
ADE | Adverse Drug Experience (US) |
ADR | Adverse Drug Reaction |
AE | Adverse Event (EU), Adverse Experience (US) |
AR | Assessment Report |
ASMF | Active Substance Master File |
ASR | Annual Safety Report |
ATC-Code | Anatomical Therapeutic Chemical-Code (WHO) |
ATMP | Advanced Therapy Medicinal Product |
B | |
BE | Bioequivalence |
C | |
(C)CDS | (Company) Core Data Sheet |
CA | Competent Authority |
CAPA | Corrective and Preventive Action |
CBER | Center for Biologics Evaluation and Research Committee for the evaluation of biologic products at the FDA |
CCSI | Company Core Safety Information |
CDA | Confidential Disclosure Agreement |
CDER | Center for Drug Evaluation and Research |
CFR | Code of Federal Regulations (US) |
CHMP | Committee for Medicinal Products for Human Use |
CIOMS | Council for International Organization of Medical Sciences |
CMD(h) | Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human |
CMS | Concerned Member State |
CTD | Common Technical Document or Clinical Trial Document or Clinical Trials Directive (officially Directive 2001/20/EC) |
CTDMB | Clinical Trial Data Monitoring Board |
D | |
DCP | Decentralised Procedure |
DCSI | Development Core Safety Information |
DLP | Data Lock Point |
DMC | Data Monitoring Committee |
DSMB | Data Safety Monitoring Board |
E | |
EBD | European Birthdate |
EC | European Commission or Ethics Committee |
E | |
eCTD | electronic Common Technical Document |
E | |
EEA | European Economic Area |
EEA | European Economic Area |
EMA | European Medicines Agency |
EPAR | European Public Assessment Report |
EU | European Union |
EudraCT | European Clinical Trials Database |
EV | EudraVigilance |
EVCT | Eudravigilance Clinical Trial Module |
EVMPD | EudraVigilance Medicinal Product Dictionary |
EVPM | Eudravigilance Post-Authorisation Module |
EVPRM | EudraVigilance Product Report Message |
F | |
FDA | Food and Drug Administration (US) |
FU(P) | Follow up |
G | |
GCP | Good Clinical Practice |
GL | Guideline |
GMP | Good Manufacturing Practice |
GVP | Guideline on Good Pharmacovigilance Practices |
H | |
HA | Health Authority |
HBD | Harmonised Birth Date |
HMA | Heads of Medicines Agencies |
HP | Healthcare Professional |
I | |
IB | Investigator’s Brochure |
IBD | International Birthdate |
IC | Informed Consent |
ICD | Informed Consent Document or International Code of Diseases |
ICF | Informed Consent Form |
ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
ICH | International Conference on Harmonization |
ICSR | Individual Case Safety Report |
IDMB | Independent Data Monitoring Board |
IMP | Investigational Medicinal Product |
IND | Investigational New Drug |
IT | Information Technology |
L | |
LLT | Low Level Term |
LoQ | List of Questions |
M | |
M & S | Marketing & Sales |
MA | Marketing Authorisation |
MAA | Marketing Authorisation Applicant |
MAH | Marketing Authorisation Holder |
MedDRA | Medical Dictionary for Regulatory Activities |
MFR | Manufacturer |
MHRA | Medicines and Healthcare products Regulatory Agency (UK) |
MLM | Medical Literature Monitoring |
MP | Medicinal Product |
MRP | Mutual Recognition Procedure |
MS | Member State |
MSSO | Maintenance and Support Services Organization (MedDRA) |
N | |
N/A | Not applicable |
NCA | National Competent Authority |
NDA | New Drug Approval or New Drug Application |
NS | Non-serious |
NtA | Notice to Applicants |
O | |
OMP | Orphan Medicinal Product |
OTC | Over-the-counter (non-prescription medicines) |
P | |
PA(D)ER | Periodic Adverse (Drug) Experience Report |
PAES | Post Authorisation Efficacy Study |
PASS | Post Authorisation Safety Study |
PBRER | Periodic Benefit-Risk Evaluation Report |
PhV | Pharmacovigilance |
PI | Package Insert or Product Information or Principle Investigator or Parallel Import |
PIP | Paediatric Investigation Plan |
PK | Pharmacokinetics |
PL | Package Leaflet |
PQR | Product Quality Review |
PRAC | Pharmacovigilance Risk Assessment Committee |
PSMF | Pharmacovigilance System Master File |
PSUR | Periodic Safety Update Report |
PSUSA | PSUR Single Assessment |
PT | Preferred Term |
PUMA | Paediatric Use Marketing Authorisation |
PV | Pharmacovigilance |
PVA | Pharmacovigilance Agreement |
Q | |
QA | Quality Assurance |
QA | Quality Assurance |
QC | Quality Check |
QC | Quality Check or Quality Control |
QM | Quality Management |
QP (GMP) | Qualified Person (Good Manufacturing Practice) |
QPPV | Qualified Person responsible for Pharmacovigilance |
QRD | Quality Review of Documents |
R | |
R & D | Research & Development |
RA | Regulatory Affairs or Regulatory Authority |
RAS | Rapid Alert System |
REG | Regulation |
RMP | Risk Management Plan |
RMS | Reference Member State |
RSI | Reference Safety Information |
S | |
SA | Scientific Advice |
SADR | Serious Adverse Drug Reaction |
SAE | Serious Adverse Event |
SC | Study Coordinator |
SD | Source Data / Source Document or Single Dose or Standard Deviation |
SDEA | Safety Data Exchange Agreement |
SDS | Signal Detection Spreadsheet |
SEQ | Safety, Efficacy, Quality |
SESAR | Suspected Expected Serious Adverse Reaction |
SME | Significant Medical Event or Small and Medium Enterprises |
SMF | Site Master File |
SmPC | Summary of Product Characteristics |
SMQ | Standardised MedDRA Queries |
SOP | Standard Operating Procedure |
SPC | Supplementary Protection Certificate |
SRC | Safety Review Committee |
SUSAR | Suspected Unexpected Serious Adverse Reaction |
T | |
TPM | Third Party Manufacturer |
V | |
VAERS | Vaccine Adverse Event Reporting System |
VeDDRA | Veterinary Dictionary for Drug Related Affairs |
VMP | Veterinary Medicinal Product |
W | |
WHO | World Health Organisation |
WP | Working Procedure |
X | |
XEVMPD | eXtended Eudravigilance Medicinal Product Dictionary |
XML | Extensible Markup Language |