Topics
- Assessing Adverse Event Cases
- Overview of Pharmacovigilance
- Global Regulatory Requirements
- Reporting Adverse Events
- Pharmacovigilance Best Practices
- Inspections and Audits
- Case Studies with Real-Life Inspection Findings
- Preparing for an Inspection
- Pharmacovigilance and Risk Management Process
- Background to Signal Detection
- Signalling and Data Mining Exercises
Who should Attend
Regulatory Affairs, Pharmacoepidemiology , Pharmacovigilance Specialists, Clinical Safety Staff, Quality Management Specialists, Regulatory Affairs Professionals, Regulatory Affairs, Drug Safety and Pharmacovigilance, Executives with any Legal Responsibility for Drug Safety and Clinical Development.
