Medical Product Safety and Pharmacovigilance

MSP 110  Introduction to Medical Product Safety

This course provides a comprehensive introduction to medical product safety and pharmacovigilance. Topics include an overview of the key components of product safety, product safety terminology, the processes for monitoring product safety, and the regulations that govern product safety and pharmacovigilance. Upon completion, students should be able to describe the processes for monitoring the safety of drugs, diagnostics, medical devices, and biologics throughout a product's life cycle.

Course Hours Per Week: Class, 3; Lab, 0
Semester Hours Credit: 3
Prerequisite: Restricted to Clinical Trials or Medical Product Safety students
Corequisite: None
MSP 110 Course Outiline: Not Available

MSP 115  Medical Product Safety Regulations

This course provides an overview of national and global regulations governing the safety of medical products including drugs, diagnostics, medical devices, and biologics. Topics include a review of the regulatory agencies; regulations for pre-clinical, clinical, and post-market production safety; and regulations governing the process for monitoring product safety. Upon completion, students should be able to demonstrate a basic understanding of regulatory processes associated with clinical research and describe effective means of compliance.

Course Hours Per Week: Class, 3; Lab, 0
Semester Hours Credit: 3
Prerequisite: Restricted to Clinical Trials or Medical Product Safety students
Corequisite: None
MSP 115 Course Outiline: Not Available

MSP 120  Safety Reporting

This course provides an overview of the criteria utilized in determining how safety data are reported. Emphasis is placed on learning the purpose, content, and format of the various reports that include safety information. Upon completion, students should be able to describe the difference between expedited and periodic reporting, the criteria used in this determination, as well as the purpose and content of each type of safety report.

Course Hours Per Week: Class, 3; Lab, 0
Semester Hours Credit: 3
Prerequisite: Restricted to Clinical Trials or Medical Product Safety students
Corequisite: None
MSP 120 Course Outiline: Not Available

MSP 130  Safety Systems and Processes

This course provides an introduction to product safety systems, the collection and processing of safety data, and data coding. Emphasis is placed on the importance of quality data, the steps in case processing, and experience in entering case data. Upon completion, students should be able to discuss and perform the essential steps in processing a case from beginning to end for both pre-marketing and post-marketing cases.

Course Hours Per Week: Class, 3; Lab, 3
Semester Hours Credit: 4
Prerequisite: Restricted to Clinical Trials or Medical Product Safety students
Corequisite: None
MSP 130 Course Outiline: Not Available

MSP 150  Medical Product Safety Fieldwork I

This course provides supervised work experience and observations in a medical product safety research setting. Emphasis is placed on the enhancement of professional skills and the practical application of curriculum concepts in a research setting. Upon completion, students should be able to describe research theory effectively to medical product safety/pharmacovigilance research practices.

Course Hours Per Week: Class, 0; Lab, 0; Clinical, 15
Semester Hours Credit: 5
Prerequisite: Take All: MSP 110, MSP 115, MSP 120, and MSP 130
Corequisite: None
MSP 150 Course Outiline: Not Available

MSP 220  Signal Detection & Risk Assess

This course provides a basic understanding of the analysis of data to identify safety signals and to determine a product's risk profile to ensure a medical product has a favorable benefit-risk balance through its life cycle. Topics include the rationale and methods used in analyzing single cases versus aggregate data. Upon completion, students should be able to synthesize work in case processing, safety systems, safety reporting and regulations to assess a product's benefit-risk, as well as to identify the issues in ongoing benefit-risk assessments and demonstrate a basic understanding of how signaling and risk assessments are done.

Course Hours Per Week: Class, 3; Lab, 3
Semester Hours Credit: 4
Prerequisite: Restricted to Clinical Trials or Medical Product Safety students
Corequisite: None
MSP 220 Course Outiline: Not Available

MSP 250  Med Prod Saf Research Field II

This course provides advanced work experience in a medical product safety/pharmacovigilance research setting. Emphasis is placed on the refinement of professional skills and the practice of curriculum concepts in diverse medical product safety research areas. Upon completion, students should be able to apply research theory to medical product safety/pharmacovigilance practices.

Course Hours Per Week: Class, 0; Lab, 0; Clinical, 24
Semester Hours Credit: 8
Prerequisite: Restricted to Clinical Trials or Medical Product Safety students
Corequisite: None
MSP 250 Course Outiline: Not Available

 

 

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