Investigational Review Board and FDA Warning Letters

Instructor: Kesley Tyson
Product ID: 704786
  • Duration: 60 Min
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Read Frequently Asked Questions

This training program will identify regulations and guidelines pertaining to institutional review boards. Attendees will learn about the historical events leading up to today’s regulatory framework in clinical research as well as discuss recent ethical issues regarding the IRB. The course will also explore the emergence of IRBs that are not academically affiliated.

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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