Abb Flashcards
OPAL
Online Product Authorization and Lifecycle.
Opal is used to manage submission planning and track registration details for both clinical trials and marketed products.
PD
Product development
PDS
Product details at
PIP
Pediatric investigation plan
APIP is a regulatory submission to support pediatric development of a product.
QuAD
CMC regulatory questions and answers database
RADAR
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.
REQUIRE
Intelligent system used to manage regulatory requirements
RIS
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
SDA
Shared document area
SIM
Submission issues and messages
Submission specialist
Central regulatory staff responsible for CMC related authoring/publishing support activities
SWP
Submission writing process
SWT
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“.
TMF
Trial Master file
MSR
Market specific requirement
Information required specifically by a market such as a certification of analysis (CoA)
Module
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
MAA
Marketing authorization application
LOC
Local operating company (GSK)
IMMS
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.
iCTD
International common technical document
GRS
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
CRO
Contract research organization
ECHO
Electronic correspondence handling and organization
Echo is a correspondence management system designed for the global regulatory affairs groups
GMS
Global manufacturing and supply
GRA
Global regulatory affairs
GRACE
Global regulatory Archiving and e-Management system
Repository for regulatory correspondence and submissions
GRPD
Global regulatory platforms and delivery
GRS
Global regulatory strategy
The GRS guides the development of innovated regulatory strategies to align with the overall business strategies for product development lifecycle management.
CF
Contributing function
PAC
Post approval committees
QRG 2058
Quick reference guide
GQP 1204
GQP Validation lifecycle
