Acronyms Flashcards

1
Q

BEC

A

BRAIN event code

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2
Q

BoM

A

Bill of Materials

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3
Q

BRAIN

A

BHC Regulatory Affairs Information System

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4
Q

BWH

A

Betriebswichtige Hinweise

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5
Q

CA

A

Change Application

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6
Q

CAT

A

Change Assessment Tool

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7
Q

CCDS

A

Company Core Data Sheet

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8
Q

CM

A

Change Management

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9
Q

CP

A

Centralised Procedure (EU)

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10
Q

CRF

A

Change Request Form

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11
Q

D

A

Decision Point

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12
Q

eCTD

A

Electronic Common Technical Dossier

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13
Q

eDMS

A

Electronic Document Management System

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14
Q

EMA

A

European Medicines Agency

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15
Q

EN

A

European Norm

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16
Q

GCM

A

Global Change Management in PS

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17
Q

GLM

A

Global Labeling Manager

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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
Q

GSM

A

Global Submission Management

26
Q

HA

A

Health Authorities

27
Q

ICH

A

International Conference on Harmonization

28
Q

LRAM

A

Local Regulatory Affairs Manager

29
Q

MAA

A

Marketing Authorization Application

30
Q

MDCDS

A

Medical Device Core Data Sheet

31
Q

MPM

A

Marketed Product Manager

32
Q

NDA

A

New Drug Application

33
Q

NoS

A

Notification of Submission

34
Q

OI

A

Operational Instruction

35
Q

PAC

A

Post Approval Commitment

36
Q

PDS

A

Product Detail Set (entity in BRAIN)

37
Q

PIL

A

Patient Information Leaflet

38
Q

PS

A

Product Supply

39
Q

SCF

A

Specification and Component File (artwork and BoM elements for sign off by the LRAM)

40
Q

SHCP

A

Social HealthCare Product

41
Q

SKU

A

Stock Keeping Unit

42
Q

TRD

A

Technical Registration Document

43
Q

WHO

A

World Health Organization

44
Q

wTOC

A

Working Table of Contents