QSEM

Question 1

Quality topics

Answer 1

Topics relating to pharmaceutical and chemical quality assurance

Question 2

Safety topic

Answer 2

Topic relating to invitro and invivo pre clinical studies

Question 3

Efficacy topics

Answer 3

Topics relating to clinical studies in human subjects

Question 4

Multidisciplinary topics

Answer 4

Cross cutting topics which do not fit uniquely in any of the above categories

Question 5

Quality topic example

Answer 5

Q1 : STABILITY TESTING
Q3: Impurity testing

Question 6

Safety topic example

Answer 6

S1: carcinogenecity testing
S2: genotoxicity testing

Question 7

Efficacy testing example

Answer 7

E4: dose response studies, carcinogenecity testing,E6: GCP

Question 8

Multidisciplinary topic example

Answer 8

M1 medical terminology(medDra)
M3 timing of pre clinical studies in relation to clinical trials