#1 Flashcards
1
Q
COMP
A
committee for orphan medicinal product
2
Q
HMPC
A
comityee on herbal medicinal product
3
Q
PDCO
A
paediatric committee
4
Q
CAT
A
committee for asvanced therapies
5
Q
PRIME
A
scheme for accelerated assessment for the MA of medicine with unmet medical need
6
Q
MedDRA
A
medical dictionary for regulatory activities
7
Q
EPAR
A
european public assesment report
8
Q
orphan medicine
A
medicine for diagnosis prevention or trwtmetn that is rare, lifethreatning or chronically debilitating that costs too much to devleop to generate sufficient profit
9
Q
advanted therapy are
A
gene therapy
cell therapy
tissue engineering
10
Q
biosimilar
A
biological of which safety/ quality / efficacy the same to reference biologicL
