Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

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.

Areas Covered in the Session:

Upon completing this course on the "Best Practices for 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

Who Will Benefit:

This course is designed for people tasked with developing drug products, biologics and medical devices; and responsible for overseeing a company's clinical development program and regulatory strategies.  This includes individuals responsible for overseeing regulatory affairs, developing strategies for establishing data safety monitoring plans, establishing adverse event databases, submitting timely safety reports to comply with regulatory compliance and those tasked with ensuring corporate compliance. Among others, this includes:

• Quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Medical device professionals
• Biotechnology and pharmaceutical professionals
• Clinical Investigators
• Study Monitors
• Quality auditors
• Data analysis specialist
• Document control specialists
• Record retention specialists
• Medical affairs
• Marketing Staff