Course Description

As many organizations move to, or contemplate, a risk-based approach to trial conduct and quality management, the published regulatory agency documents and industry think tank publications fall short in providing sponsors, CROs, and clinical vendors the framework—a comprehensive, systematic, structured approach to implementing risk management. This web seminar will provide an overview of a risk management reference model for use that has been adopted by other industries and is referenced in the FDA Guidance of 2013, “Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring.”

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Learning Objectives

• Describe the guiding principles when implementing a risk management framework
• Describe the attributes of a risk management framework
• Explain the rationale for knowing an organization’s definition for risk

Who Should Attend

• Sponsor and Vendor Personnel responsible for trial oversight
• Clinical Research, Operations, and Development Professionals

Instructor

The course will be led by one of the following instructors:

Liz Wool, R.N., B.S.N., C.C.R.A., CID, CMT

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.