Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products 2016

Topics

• Roles and Responsibilities of the Investigational Site and Sponsor in AE Reporting
• Adverse Event (AE) and Serious Adverse Event Terminology: Definitions
• Causality Assessments
• Exclusions from SAE Reporting
• Investigator Notification Letters/ IND Safety Reports
• Site Obligations
• Case Studies and Scenarios

Who should Attend

• Contract Research Organization
• Clinical Research Site
• Clinical Research Associate
• Clinical Research Coordinator
• Principal Investigator
• Regulatory Coordinator
• Safety surveillance
• Sub-Investigator
• Pharmacovigilance
• PVG
• QA/QC