| BTRA 640 |
Preclinical and Clinical Research Design (3) |
An examination of preclinical and clinical research designs. Emphasis is on identifying and addressing challenges associated with elements of good laboratory and clinical practice and qualifying and managing a laboratory for a clinical trial. Discussion covers best practices for planning research and collecting, analyzing, and reporting data from drug/device development studies. |
| Start date has passed. Please register for the next start date. |
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24952 |
9040 |
10 Jan 2024-02 Apr 2024 |
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Open |
Online |
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Faculty: Guedez, Liliana |
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| BTRA 641 |
Product Life Cycle Approval, Production, and Marketing for Devices and Drugs (3) |
An in-depth study of the product life cycle for medical devices and implants and pharmaceuticals. Focus is on the various stages within the life cycle from conceptualization of a product pipeline in research and development through postmarket surveillance and production. Topics include regulatory submission, approval, production, and the postmarket environment for both drugs and devices. Challenges surrounding the approval and naming of follow-on biologics are addressed. Discussion also covers combination medicines, the stages of a drug pipeline and risk assessment at each stage, and the decreasing productivity of the drug pipeline. The role of a contract research organization in testing and approval is explained, and the nature of the support services they provide to the biotechnology and devices industry is explored. |
| Start date has passed. Please register for the next start date. |
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24953 |
9040 |
10 Jan 2024-02 Apr 2024 |
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Open |
Online |
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Faculty: Foreman, Angela Lee |
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Course Materials
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| BTRA 642 |
Global Biotechnology Business Issues (3) |
An exploration of different aspects of international pharmaceutical regulation, as outlined in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topics include international biotechnology issues, global harmonization efforts, and the cultural impact of biotechnologies. Discussion also covers domestic and international business considerations and international regulatory requirements. |
| Start date has passed. Please register for the next start date. |
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25040 |
9040 |
10 Jan 2024-02 Apr 2024 |
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Open |
Online |
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Faculty: Cotterell, Alison A |
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| BTRA 643 |
Practical Applications of Biotech Regulatory Affairs (6) |
A capstone study of regulatory affairs related to the biotechnology industry that integrates knowledge and skills gained from previous study. Emphasis is on completion of a group project simulating the development of a drug or device through the product life cycle. The project is designed to demonstrate knowledge of international biotech business, ethics, and production issues and skills in making decisions regarding a wide range of regulatory issues and to provide a transition for applying these skills to applications in the biotechnology environment. |
| Start date has passed. Please register for the next start date. |
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24970 |
9040 |
10 Jan 2024-02 Apr 2024 |
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Open |
Online |
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Faculty: Mitchell, Maika G |
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