Roche Vigilance Training Flashcards
1
Q
Another name for adverse events
A
potential side effects
2
Q
Special situations definition
A
additional reportable events about Roche medicine that Roche is required to monitor,
Examples: pregnancy, breastfeeding.
3
Q
Examples of product complaints
A
something is wrong with a Roche product:
medicine, device, software, reagents
4
Q
How quickly must complaints be reported
A
1 business day.
5
Q
who should I contact about a product complaint and what info do I share?
A
expert vigilance function: local safety or quality assurance unit for pharmaceuticals or diagnostics and diabetes care. share: side effect and Roche product
6
Q
PREP is an acronym for reporting. What does it stand for?
A
Patient, reporter, event, product
