Regulatory Flashcards
1
Q
EMEA
A
European Medicines Agency
2
Q
ELN
A
Electronic Laboratory Notebook
3
Q
SRA
A
Sponsored Research Agreement
4
Q
WTO
A
World Trade Organization
5
Q
PhAT
A
Pharmaceutical Audit Trail
6
Q
MA DPH
A
Massachusetts Department of Public Health
7
Q
BLA
A
Biologic License Application
8
Q
The division of the FDA that handles SMs and ASOs
A
CDER
9
Q
IRB
A
Institutional Review Board
10
Q
FDA
A
Food and Drug Administration
11
Q
Department of the FDA that handles gene therapies
A
OTAT
12
Q
CBER
A
Center for Biologics, Evaluation and Research
13
Q
OTAT
A
Office of Tissues and Advanced Therapies
14
Q
TGA
A
Therapeutic Goods Administration
Australia’s Regulatory Agency
15
Q
LIMS
A
Laboratory Information Management System
