The Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products 2016 is a webinar that covers topics such as:
- 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
The Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products 2016 is intended for:
- Contract Research Organization
- Clinical Research Site
- Clinical Research Associate
- Clinical Research Coordinator
- Principal Investigator
- Regulatory Coordinator
- Safety surveillance
- Sub-Investigator
- Pharmacovigilance
- PVG
- QA/QC