ADR Management and Reporting 2014

Topics

• Regulatory reporting - Individual and Aggregate reporting
• Aggregated data assessment and interpretation
• Affiliate Workflow
• Adverse Drug Reactions - Case Intake from different sources
• A brief overview of ICH and other regulatory guidelines
• Interactions and risk factors
• Assessment of individual case reports
• Frequency estimation
• Signal detection

Who should Attend

Professionals are involved in::

• Clinical Research
• Pharmacovigilance (including QPPV)
• Drug Safety Assessment Department
• Risk Management
• Pharmacoepidemiology
• Safety Data Analysis
• Regulatory Affairs
• Information Technology
• Quality and Compliance
• Pharmacovigilance consultancy
• Legal