PTI - international

• Comply with all regulations governing pharmacovigilance
• Determine the differences between a risk management program and a pharmacovigilance plan
• Implement an effective and thorough pharmacovigilance plan
• Determine what to include in a good case report
• Clarify the role of pharmacoepidemiology in risk management
• Design and submit effective, timely pharmacoepidemiology studies

Exercise: Case Study on Good Pharmacovigilance Practices

VI. Determine Best Practices for Drug Safety Reporting

• Code suspected adverse reactions (SADRs) on the basis of MedDRA
• Write effective, timely PSURS
• Explore FDA initiative designed to enhance timely collection of SADRs
• Identify the impact of medication errors
• Comply with ICH requirements for safety reporting

Exercise: Question and Answer Session on FDA's Rewrite of Drug Safety Reporting Requirements Regulation (The TOME)

VII. Establish an Effective Risk Management Program

• Identify the benefits of a establishing a risk management program
• Define FDA terms and analyze final guidances on risk management planning/programs
• Determine key elements to cover in a risk management program
• Involve key personnel: qualifications, training, management
• Appropriately time the submission of your risk management plan
• Identify new requirements outlined in PDUFA III

Exercise: Case Study on Risk Management Program Solution and Wrap-Up Q&A