L13 HSA Flashcards
1
Q
What is the process of safety vigilance?
A
Slide 10
- Risk detection > Assessment > Minimization > Communication
2
Q
Where are the sources for risk detection?
A
Slide 10
3
Q
How is risk assessment done?
A
Slide 11
4
Q
How is risk minimization done?
A
Slide 12, 13, 14
5
Q
What is the purpose of risk communication?
A
Slide 14, 15, 16, 17
6
Q
What are some case studies regarding ADE and product recalls?
A
- SJS and TEN with carbamazepine (Slides 18-23)
- Contact lens (Slide 24 - 28)
- Slim 10 (Slide 28 - 34)
