Course Description

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

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Learning Objectives

• Appreciate the changing regulatory climate and the impact on safety reporting in clinical trials
• Explain the global response and recommendations for more meaningful safety reporting between stakeholders
• Describe the FDA’s response: January 2009 Final Guidance
• Describe the OHRP’s response: January 2007 Final Guidance
• Recognize implications for current practices
• Examine case scenarios

Who Should Attend

• Sites: Principal Investigators, Clinical Research Coordinators, Managers
• Sponsors: Clinical Research Associates, Sponsor Clinical Operations, Safety Information Specialists, Regulatory Professionals

Instructor

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

Elizabeth Ronk Nelson, M.P.H.

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