Investigational Review Board and FDA Warning Letters

Why Should You Attend:

This webinar will:

• Recognize historical events that lead to the development of the IRB
• Translate regulations and guidance into practical applications to help keep your IRB compliant
• Differentiate between local and central IRBs
• Discuss IRB ethical infractions and current trends

Areas Covered in the Webinar:

• Identify historical events that lead to the development of institutional review boards
• Identify current regulations and guidelines for the IRB
• Explore the emergence of IRBs that are not academic affiliated
• Review case studies of IRB FDA 483 warning letters

Who Will Benefit:

• Principal Investigator
• Clinical Study Manager
• Clinical Data Management Specialist
• Clinical Research Associate
• Clinical Research Coordinator/Nurse
• Data Manager
• Regulatory Coordinator
• Clinical Research Operations Coordinator
• Clinical Research Operations Manager
• Project Manager
• Clinical Trial Associate
• Clinical Trial Manager
• Clinical Research Manager

Instructor Profile:

Kesley D. Tyson, MS, CCRP, is the start-up and compliance coordinator to the Center for Clinical and Translational Research in the department of pediatrics at Emory University where she provides consulting services in all aspects of clinical research to investigators, provides data and safety monitoring for investigator initiated drug and device studies, and oversees research staff educational development initiatives.

She also provides group and one-on-one training in study start-up activities, regulatory, and project management topics. Her former experience includes being a lead research coordinator at both, Children’s Healthcare of Atlanta, Aflac Cancer and Blood Disorders Center where she provided oversight for all aspects of clinical research in the hemostasis and thrombosis program and Boston Children’s Hospital in the department of orthopedic surgery in the division of sports medicine where she served as the primary point of contact for research operations.

In addition, Ms. Tyson serves on several advisory committees at Emory University including the Clinical Trials Advisory Committee and Clinical Research Coordinator Advisory Committee. Ms. Tyson also consults for a number of companies in regulatory and compliance, conducts a number of training courses, and is active in the Society of Clinical Research Associates where she served as the co-chairman of the Atlanta chapter in 2014. Along with her experience, she has acquired a Master of Science degree in regulatory affairs for drugs, biologics, and medical devices from Northeastern University in Boston, MA and a Bachelor of Science degree in health sciences from the University of Alabama at Birmingham.

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