Acronyms Flashcards
(44 cards)
1
Q
BEC
A
BRAIN event code
2
Q
BoM
A
Bill of Materials
3
Q
BRAIN
A
BHC Regulatory Affairs Information System
4
Q
BWH
A
Betriebswichtige Hinweise
5
Q
CA
A
Change Application
6
Q
CAT
A
Change Assessment Tool
7
Q
CCDS
A
Company Core Data Sheet
8
Q
CM
A
Change Management
9
Q
CP
A
Centralised Procedure (EU)
10
Q
CRF
A
Change Request Form
11
Q
D
A
Decision Point
12
Q
eCTD
A
Electronic Common Technical Dossier
13
Q
eDMS
A
Electronic Document Management System
14
Q
EMA
A
European Medicines Agency
15
Q
EN
A
European Norm
16
Q
GCM
A
Global Change Management in PS
17
Q
GLM
A
Global Labeling Manager
18
Q
GRA
A
Global Regulatory Affairs
19
Q
CRA CM
A
GRA Change Management
20
Q
GRA CMC
A
GRA Chemistry, Manufacturing, Control
21
Q
GRA CoM
A
GRA Compliance Management
22
Q
GROC
A
Global Regulatory Operations & Compliance
23
Q
GROC-I
A
GROC International
24
Q
GRS
A
Global Regulatory Strategist
25
GSM
Global Submission Management
26
HA
Health Authorities
27
ICH
International Conference on Harmonization
28
LRAM
Local Regulatory Affairs Manager
29
MAA
Marketing Authorization Application
30
MDCDS
Medical Device Core Data Sheet
31
MPM
Marketed Product Manager
32
NDA
New Drug Application
33
NoS
Notification of Submission
34
OI
Operational Instruction
35
PAC
Post Approval Commitment
36
PDS
Product Detail Set (entity in BRAIN)
37
PIL
Patient Information Leaflet
38
PS
Product Supply
39
SCF
Specification and Component File (artwork and BoM elements for sign off by the LRAM)
40
SHCP
Social HealthCare Product
41
SKU
Stock Keeping Unit
42
TRD
Technical Registration Document
43
WHO
World Health Organization
44
wTOC
Working Table of Contents
