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.
