PTI - international

• Define key concepts and terms
• Establish roles and responsibilities
• Learn how to take a proactive approach to risk management
• Analyze implication of the Institute of Medicine (IOM) report on medical care errors
• Discuss integration of global safety and global risk management
• Outline European risk management strategy vs. U.S. strategy
• Outline regulatory framework behind drug safety and risk management
• Identify potential risk issues

Exercise: Compare Participants' Backgrounds and Expectations for the Course

II. Assess Risk Effectively in the Pre-Clinical and Clinical Stages

• Implement pre-clinical safety assessments to start risk assessment activities
• Incorporate elements in clinical trials to properly generate safety data 
  • statistical plan
  • statistical protocol
  • case report form
  • safety reporting form
• Evaluate and communicate safety information generated from clinical programs
• Determine the appropriate size of a safety database
• Perform data analysis correctly to understand a product's risk profile

Exercise: Case Study - Clinical Trial Safety Solution

III. Assess Risk and Monitor Product Safety in the Post-Approval Marketing Stage

• Identify process gaps that affect risk management
• Learn potential liability exposure in clinical and post-approval marketing safety
• Design post-marketing safety studies based on clinical discoveries
• Comply with FDA and ICH regulatory requirements
• Learn how to design a risk management registry 
• Apply proper tools and practices to assess product risk post-approval
• Discuss the relationship of signal generation and risk management
• Determine what steps to take when risk management procedures fail

Exercise: Case Studies on Product Withdrawals for Safety Issues

IV. Establish Communication Link between the Clinical and Post-Marketing Teams

• Develop an effective working relationship among all team members
• Communicate proper risk management activities from the clinical phase through post-approval marketing
• Create a risk assessment continuum throughout all stages of drug development and post-approval marketing

Exercise: Interactive Discussion of Real-World Experiences