PTI - international

• Determine critical data elements
• Analyze methods of gathering all crucial information
• Maintain a comprehensive audit trail
• Highlight unclear factors and triggering data
• Determine best ways to capture and exchange safety data

VIII. Ensure Effective Reporting Systems

• Determine what to document and how to best report findings to the Drug Information Service
• Address HIPAA reporting issues
• Gather patient specific information using an ADR Report and the Preventability and Causality Data Collection Form

Exercise: Critique Sample ADR Reports and Distinguish the Differences Between Significant and Insignificant Reports

IX. Validate Your Safety Data Systems

• Determine the key elements of a validation plan as it relates to safety
• Clarify the scope of what is to be validated
• Ensure the proper resources and personnel for validating a safety data system
• Incorporate documenting change control

X. Implement Electronic Submissions of Adverse Events

• Outline the FDA's expectations for electronic submissions
• Explore the ICH's current set of guidelines that determine common data elements
• Implement E2B files according to guidelines
• Determine the benefits of electronic case safety reports
• Identify how best to use web-based pharmacovigilance

XI. Formulate a Systematic Approach for Reporting ADRs to Allow Appropriate Analysis and Intervention

• Maintain a patient specific database of ADR information
• Analyze ADR statistics to identify common trends
• Use the FDA's MedWatch program

XII. Implement Proven Techniques for Crisis Management

• Identify potential conflicts and reactions
• Determine how to build a more effective detection program
• Implement training and literature to promote awareness and consequences
• Initiate changes in drug use policies, procedures and SOPs

Exercise: Case Study - Good Pharmacovigilance Practices