• Real World Evidence – Regulatory agency perspectives on the use of RWE for safety assessments
• RWE – Next generation approaches for expanding the use of RWE in safety decision-making
• ICH and CIOMS new safety projects and their expected impact on safety and pharmacovigilance: ICH E19 Expert Working Group (Optimisation of Safety Data Collection), CIOMS Working Group XI (Patient Involvement), CIOMS MedDRA Labelling Groupings (MLGs), and discussion of the ICH E2D Guideline (Post-Approval Safety Data Management)
• Drug Induced Liver Injury (DILI) – current research on the mechanisms of injury and the ability to predict DILI from non-clinical and clinical research
• Special considerations in benefit-risk assessment of immune-oncology therapies

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

• Drug Safety/Pharmacovigilance
• Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
• Benefit-Risk Assessment and Communication
• Medical Product Safety Assessment
• Regulatory Affairs
• Clinical Research
• Pharmacoepidemiology
• Post-Market Studies and Real World Evidence Generation
• Customer Engagement Programs, including Patient Support Programs
• Medical Information, Medical Communications
• Health Outcomes

It is also designed for professionals who work for:

• Industry: Pharmaceuticals, Biologics, Combination Products, Devices
• Clinical Research Organizations, Contract Service Organizations
• Academic Research Centers
• Regulatory Agencies
• Government Research Programs
  

• Apply the current regulatory framework for pharmacovigilance in key markets, including the US and the changing EU
• Discuss the impact of current pharmacovigilance conditions, regulatory requirements, and recent developments in India, China, and Japan on safety and pharmacovigilance practice in those markets
• Describe new ICH and CIOMS pharmacovigilance projects underway and their importance to evolving best practices in patient engagement and safety data collection
• Discuss current research findings on mechanisms of risk such as drug-induced liver injury (DILI) and their impact on assessing benefit-risk associated with therapies, including new and advanced therapies
• Compare and contrast risk management tools, such as REMS and RMPs, approved by various regulatory agencies; and discuss risk management strategies that have achieved successful implementation in a complex global setting
• Explain new approaches for surveilling medication errors and effective methods to prevent and reduce these errors
• Describe new approaches and opportunities to use RWE for safety assessment and evidence generation