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World of Compliance Module
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Risk Management and Drug Surveillance
comprehensive
Learning Objectives
Overview
Drug Registration and Listing
Adverse Drug Experience (ADE) Reporting Program
Drug Quality Reporting System (DQRS)
Risk Evaluation and Mitigation Strategies (REMS)
Knowledge Check
FAQ
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Knowledge Check
Which of the following is not considered an adverse drug experience?
Overdose
Withdrawal symptoms
Known side effects
Failure of expected pharmacological action
Which is not true of the Drug Quality Reporting System (DQRS)
It is mandatory
Most reports are received from health care workers
Reports are received by mail, phone, fax or internet
Quality issues may result in sample collection or inspection
A field alert report is required when further investigation is needed and corrective action must be taken by a firm. Which of the following does corrective action include?
Revising the formulation
Changing the label
Recalling the product
All of the above
Risk Evaluation and Mitigation Strategies (REMS) apply to drugs, biologics and generics with special limitations.
True
False
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Topic: page 1 of 1 (Lesson: page 24 of 30)
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