ICH Guidelines Flashcards
1
Q
E2A
A
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
2
Q
E2B
A
Clinical Safety Data Management: Date Elements for Transmission of Individual Case Safety Reports (ICSR)
3
Q
E2C
A
Periodic Benefit-Risk Evaluation Report
4
Q
E2D
A
Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
5
Q
E2E
A
Pharmacovigilance Planning
6
Q
E2F
A
Development Safety Update Report
7
Q
M1
A
MedDRA Terminology
8
Q
M4
A
Common Technical Document
