FDA IDE: Investigational Device Exemption - What You Need To Know

Why Should You Attend:

This webinar will focus on:

• Identifying historical events that lead to the development of the regulatory environment surrounding clinical research
• Translating regulations and guidance into practical applications to help keep your study compliant
• Practice safeguards to ensure compliance
• Real-life case studies and the dos/don’ts of conducting device studies

Areas Covered in the Webinar:

• Identify historical events leading to the regulatory framework for conducting research utilizing devices
• Identify current regulations and guidelines for devices
• Describe types of devices and class categories
• Explain 510k and PMA
• Discuss unanticipated effect reporting
• Discuss case studies of device 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 Manager
• Project Manager
• Clinical Trial Associate
• Clinical Trial Manager
• Academia
• Sponsor Investigators
• Start-Up Clinical Trial Companies
• New Investigators/Clinical Research Staff
• Clinical research sites that conduct the following: investigator initiated research, interventional studies, or FDA regulated studies

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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