Courses
Find interesting courses taught or taken by people in the Owlstown community.
Medical Device Regulation and Development
Description
The primary goal of this course was to analyze the overall framework for the regulation of medical devices in the United States throughout the product lifecycle, including the origins and rationale for regulatory requirements, design,...
Course · January 25, 2022
Responsible Conduct of Research
Description
This course was designed to provide a context for the historical evolution of current Human Subjects Protection Programs and the mechanisms developed to guide researchers and protect the rights of research subjects. An in-depth examin...
Course · January 20, 2022
Scientific and Research Review Boards
Description
This course included analysis of the value, function, authority, and regulations underlying scientific and research review boards, including institutional review boards (IRBs), institutional animal care and use committees (IACUCs), ra...
Course · January 20, 2022
Clinical Research Operations
Description
The course provided the knowledge and operational skills necessary to develop, implement, and manage a clinical trial including budget and contract negotiations, clinical trial site evaluation and selection, marketing and advertising ...
Course · January 20, 2022
Fundamentals of Regulatory Affairs
Description
The focus of this course was on the role of ethical clinical research and the regulatory process for new medical products. This course covered the origins and current status of laws and regulations as they pertain to the development, ...
Course · January 20, 2022
Clinical Research Data Management and Technology Implementation
Description
This course focused on the standard operating procedures and best practices of study data capture and management of a regulated clinical trial. The scope of the course involved estimating the budgetary requirements for supporting data...
Course · January 20, 2022
Quality Assurance and Clinical Research
Description
This course explored basic quality assurance techniques, standards, and risk management principles from product development through the marketing of a new medical product. Course materials covered incorporating quality and quality sy...
Course · January 19, 2022
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