Topics: CLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs Quiz
The IMPD should contain information to justify the quality of any Investigational Medicinal Product (IMP) to be used in a clinical trial and include information on reference products and placebo.
A. TRUE
B. FALSE
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The IB should be reviewed at least ……………….. and revised as necessary in compliance with a sponsor’s written procedures.
A. Half yearly
B. Annually
C. Quarterly
D. Two years