Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

RPS > Abb > Flashcards

Abb Flashcards

1
Q

OPAL

A

Online Product Authorization and Lifecycle.

Opal is used to manage submission planning and track registration details for both clinical trials and marketed products.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

PD

A

Product development

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

PDS

A

Product details at

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

PIP

A

Pediatric investigation plan

APIP is a regulatory submission to support pediatric development of a product.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

QuAD

A

CMC regulatory questions and answers database

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

RADAR

A

Regulatory affairs documented advice repository.

Radar is a database that has been designed to manage the process by which sites receive CMC regulatory advice for proposed/planned changes.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

REQUIRE

A

Intelligent system used to manage regulatory requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

RIS

A

Regulatory and implementation strategy parentheses shared by GMS and may be conducted via a meeting or email/instant messaging/teleconference for straightforward changes. The regulatory and implementation strategy or plan GMS implementation and regulatory action for all changes and for all markets

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

SDA

A

Shared document area

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

SIM

A

Submission issues and messages

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Submission specialist

A

Central regulatory staff responsible for CMC related authoring/publishing support activities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

SWP

A

Submission writing process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

SWT

A

Project team comprising ribs and Tatian from CMC regulatory affairs, GSK quality, tactical experts, and other stakeholders as appropriate to support the development, authorship, review and approval of CMC dossier. May also be known as “submission project team“.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

TMF

A

Trial Master file

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

MSR

A

Market specific requirement

Information required specifically by a market such as a certification of analysis (CoA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Module

A

A module is a piece of information that is used to build customer definition information outputs, for example, submissions documents. It may vary from a small table or piece of tax to a large section of a report or even the report itself. The size of the scope of a module depend on its use in producing information helps. A key factor in determining the size of each module, identifying the contents, is the potential for reuse in more than one output

17
Q

MAA

A

Marketing authorization application

18
Q

LOC

A

Local operating company (GSK)

19
Q

IMMS

A

International modules management system

IMMS manages modules for regulatory and non-regulatory business groups from creation through to approval, making use of version control, a document lifecycle and an access rights model.

20
Q

iCTD

A

International common technical document

21
Q

GRS

A

Global regulatory strategy

The GRS guides the development of innovative regulatory strategies to align with the overall business strategies for product development and lifecycle management

22
Q

CRO

A

Contract research organization

23
Q

ECHO

A

Electronic correspondence handling and organization

Echo is a correspondence management system designed for the global regulatory affairs groups

24
Q

GMS

A

Global manufacturing and supply

25
Q

GRA

A

Global regulatory affairs

26
Q

GRACE

A

Global regulatory Archiving and e-Management system

Repository for regulatory correspondence and submissions

27
Q

GRPD

A

Global regulatory platforms and delivery

28
Q

GRS

A

Global regulatory strategy

The GRS guides the development of innovated regulatory strategies to align with the overall business strategies for product development lifecycle management.

29
Q

CF

A

Contributing function

30
Q

PAC

A

Post approval committees

31
Q

QRG 2058

A

Quick reference guide

32
Q

GQP 1204

A

GQP Validation lifecycle

RPS (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions