PTI - international

• Define an Adverse Drug Reaction (ADR)
• Examine the history of ADRs and the progress of preventative measures
• Determine the differences between drug reactions, adverse events and serious adverse events
• Analyze the needs and focus of ADR monitoring and reporting programs

Discussion: Compare and Review Participants' Experiences with ADR programs

II. Examine the Current Regulatory Guidelines Governing Adverse Event Reporting

• Clarify the regulatory framework for drug safety
• Determine how to ensure compliance when reporting drug safety data to FDA
• Determine requirements for NDA reporting
• Define scope of new changes in regulations, guidances and procedures at FDA
• Explore CDER's perspective on adverse event reporting

III. Implement Current Requirements for Safety Surveillance and Reporting

• Examine the historical background of pharmacovigilance
• Determine the impact of ICH standards on drug safety reporting
• Comply with the expectations for capturing and reporting safety information
• Explore the FDA's new proposed rule to improve safety reporting for human drugs and biologics (The TOME)
• Identify methods for capturing, processing and reporting suspected adverse events to FDA

Exercise: Case Study – The TOME

IV. Implement a Pharmaceutical Risk Monitoring System

• Determine high-risk patients
• Analyze high-risk drugs
• Monitor targeted drugs
• Formulate a reaction plan

Exercise: Case Study – PostMarketing Surveillance

V. Identify and Respond to Drug Reactions

• Determine the differences between intended and un-intended drug reactions
• Define what constitutes a reportable ADR
• Decide what criteria determines a preventable ADR
• Identify the severity of an ADR

VI. Explore the Best Ways to Implement and Manage the MedDRA Program

• Critique MedDRA and how it impacts drug safety
• Examine current FDA expectations for MedDRA usage in mandatory safety reporting
• Analyze the role of MSSO
• Explore the FDA's recommendations for implementing MedDRA
• Examine best ways to output MedDRA data for meaningful results

Exercise: Share Best Practices for MedDRA Usage