Adverse Event Reporting Understanding Regulatory Reporting Requirements
Duration : 60 Minutes
Nicole Tesar,
Nicole began her career in Clinical Research over 17 years ago as a Clinical Research Associate for a small Clinical Research Organization. The “accidental” career that began after receiving her undergraduate degree has proven to be rewarding, challenging and continues to inspire her t Read more
This webinar will provide participants with an understanding of the regulatory reporting requirements when Adverse Drug Reaction (i.e. Adverse Events) occurs at the investigational stage of a Clinical Trial.
Adverse event identification and reporting requirements will be reviewed, as well as FDA training and ICH roles in the drug safety process. The webinar will also discuss ICH training guidelines and current regulatory issues regarding adverse event reporting requirements specific to the United States.
Why Should You Attend:
• Understand what Adverse Events, Serious Adverse Events
• Learn the responsibilities of the Sponsor, Site/Clinical Investigator and Regulatory Agency in the reporting of Adverse Events
• Become familiar with current issues regarding Adverse Event reporting specific to the United States
• Have an understanding of what role the FDA and ICH Guidelines play in determining the safety of a drug
Course Objectives:
• Identify when a Serious Adverse Event does not require reporting
• Understand what the site obligations are in both assessing causality of adverse events as well as reporting these events to the sponsor
• Learn the circumstances under which Investigator Notification Letters are released as well as responsibilities for notification of clinical sites as well as the FDA
Course Outline:
• Adverse Event (AE) and Serious Adverse Event Terminology: Definitions
• Roles & Responsibilities of the Sponsor and the Regulatory Agency in AE reporting
• Exclusions from SAE Reporting
• Causality Assessments
• Site Obligations
• Investigator Notification Letters/ IND Safety Reports
• Case Studies and Scenarios
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Clinical Research Professionals
• Safety Surveillance Personnel
• Regulatory Affairs Personnel
• Medical Affairs Personnel
• QA/QC Managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
