2nd Pharmacovigilance North America 2012

Key Topics

• Good Pharmacovigilance Practice in a Global Environment: Focusing on EMA, FDA & Japanese Regulations
• A Retrospective on the Evolution of Pharmacovigilance
• Addressing the Importance of Developing & Implementing a Pre-Marketing Plan
• Spontaneous Reporting: Filling the knowledge Gaps
• Designing Post-approval Safety Studies
• FDA developments and future direction
• Developing & Implementing Strong Post Marketing Best Practices
• The Patient Perspective: Gaining & Keeping Customer Trust
• Shaping an Accurate Risk Profile of Your Drug
• Linking AE Trends: An Epidemiologist’s Perspective
• Know Your Population and Decrease Systemic Errors
• Leveraging IT to develop Efficient Operating Models
• Physician training: Spreading the word on proper AE Reporting

Who should Attend

Vice Presidents, Senior Vice Presidents, Directors, Heads, Managers, Specialists and Leaders of: Drug Safety, Pharmacovigilance, Regulatory Affairs, Clinical Research & Safety, Medical Affairs, Compliance, Risk Management, Drug Safety Scientists or Officers, Data Analysis, Medical Product Safety Assessment, Labeling, Epidemiology, Quality Assurance/Control, Scientist, Global Patient Safety and Medical Information.