At the conclusion of this workshop, participants should be able to:
· Explain key aspects of current global safety reporting requirements for prescription and over-the-counter drugs
· Discuss the latest regulatory frameworks of pharmacovigilance in the US, Europe, Japan and Asia-Pacific
· Explain the application of epidemiological approaches during drug safety surveillance
· Recognize new pragmatic approaches to pharmacovigilance as proposed by the CIOMS working groups
· Describe regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan
· Identify best practices for quality assurance in post-marketing pharmacovigilance and clinical safety
Professionals with experience in clinical safety and who are involved in: · Pharmacovigilance
· Clinical research
· Risk management
· Compliance
· Medical information
· Regulatory affairs
· Academia
· Pharmacology