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Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices – GlobalCompliancePanel
July 14, 2016 - July 15, 2016$1,495
The Food and Drug Administration’s Center for Drug Evaluation Research, Center for Biologics Evaluation Research and Center for Devices and Radiological Health are responsible for the approval of drug products, biologics and medical devices industries. This seminar begins with outlining the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act (the ACT) and how the FDA uses it to enforce the regulatory requirements during the drug, biologics and medical device approval process. Additionally, this seminar will highlight safety, which is in the FDA’s mission statement, by guiding participants on how to develop a data safety monitoring plan and when it is important to use a Data Safety Monitoring Board. Additionally, various safety management practices will be discussed and the importance of creating a functional adverse event database. This seminar will also provide the terminology necessary to establish an adverse event monitoring score and the training requirements for study monitors will be discussed in detail. IND and IDE safety reports, IND annual safety updates and DSUR will be discussed. How to troubleshoot safety events with clinical site principal investigators and how to survive an FDA audit for safety management practices will complete the agenda for this seminar.
Why should you attend:
Since 1970 the regulations for conducting clinical trials has been under the direction of the Food and Drug Administration (FDA), more specifically, FDA’s Center for Drug Evaluation and Research (CDER). CDER is the regulatory agency for drug applications, monitoring efficacy, safety and review process during all phases of clinical trials. As defined in its mission statement, “the FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” The history of clinical research involving humans introduced the Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products in 1995. GCP is the standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trial studies. These guidelines set the minimum quality standards for the conduct of clinical research. Compliance with GCP ensures that the rights, safety and well-being of study participants are protected.
Areas Covered in the Session:
Upon completing this course on the “Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices” participants will:
- Have a knowledge of the role, structure what the Food and Drug Administration (FDA) regulates
- Learn the importance of the Food, Drug and Cosmetic Act (FDCA)
- Learn how to setup a data safety monitoring plan and when to use a data safety monitoring board
- Learn the various safety management practices employed during clinical studies
- Understand the importance of the training requirements of safety monitors (investigators)
- Discuss how to create an adverse event database
- Learn the submitting process for IND/IDE safety reporting
- Understand how to troubleshooting safety events with site principal investigators
- Learn how to survive an FDA audit for safety management practices and what Bioresearch Monitoring