Clinical Safety and Pharmacovigilance  
Click on the session title for a complete description.
Day Session Link
Monday Improving Safety with Every Step: Pillars of the Pharmaceutical Landscape
Monday The ASTER Pilot One Year Later: Different Approaches to Spontaneous Reporting - A New Business Model
Monday Modernization of FDA Postmarket Adverse Event Information Management
Monday Issues and Challenges Associated with the PSUR Process
Monday Improving Safety with Every Step: Pillars of the Pharmaceutical Landscape
Tuesday Update on Clinical Safety and Pharmacovigilance in Japan
Tuesday FDA Sentinel Initiative
Tuesday Pharmacovigilance on a Budget
Tuesday Pharmacovigilance Organization Models: How New Regulatory and Business Needs Are Changing the Pharmacovigilance Department, and How to Design an Effective Organization
Tuesday Development Safety Update Report (ICH E2F): Update, Current Status, and Major Provisions
Tuesday Early Signal Information from the Regulatory Authorities: Implications for the Public and the Need for Risk Benefit Communication to Enhance Understanding
Tuesday Signal Detection and Data Mining in Pharmacovigilance: Motives, Methods, and Management
Wednesday Quantitative Benefit-risk Profile Evaluation Methods: Which to Use?
Wednesday Risk Management Best Practice: Integrating Risk Management Strategies into All Phases of the Product Life Cycle
Wednesday Observational Pharmacovigilance: Analysis Methods and Business Practices across Drug Safety Stakeholders
Wednesday The EU Risk Management Plan and US Risk Evaluation and Mitigation Strategy (REMS): Company Perspectives and Experience
Wednesday Pharmacovigilance Agreements
Wednesday Recent Advancement of Risk Management in the Asian Pacific Region
Thursday A Registry by Any Other Name
Thursday Pregnancy Registries: Perspectives on a Unique Risk Management Tool
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