Course Description

One of the top regulatory findings both in the U.S. and in global inspections is related to investigational product (IP) accountability. In this web seminar, we will discuss the common sources of error, recommend procedures and training techniques, and evaluate the differences in investigational and non-investigational products. Investigator and sponsor responsibilities will be described, as well as “best practices” for implementation of those responsibilities.

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Learning Objectives

• Describe IP accountability requirements and regulatory considerations
• Discuss non-investigational medicinal product and rescue medication management and documentation
• Define the responsibilities of the research site in IP accountability
• Develop strategies for identifying and solving IP accountability errors or deficiencies

Who Should Attend

• Investigators
• Coordinators
• Pharmacists
• Clinical Research Associates
• Project Managers

Instructor

Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP

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