Pharmacovigilance and Risk Management Strategies Conference

This year’s conference will address the current thinking on predicting and assessing risks such as drug-induced liver injury, and the assessment of expectedness of serious adverse reactions during clinical development. The complexities of assessing benefit-risk balance of today’s therapies, including immunotherapy and other advanced therapies, will be examined. Experts will present approaches and engage in dialogs around more extensive and impactful uses of real world data and generation of RWE for safety assessments. A full day will be devoted to the development, implementation, and assessment of risk management strategies for drugs approved in multiple regions, with a special in-depth coverage of REMS in the US.

In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements.

“One of the best conferences I have attended. A broad view on how far we have come in the world of PV, why we do what we do, and what is still to come ot meet future needs of patients and managing benefit-risk.” – Mary Welke, Trilogy Writing & Consulting, Inc

• 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

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical involved in:

• Drug Safety
• Pharmacovigilance
• Risk Management
• Clinical Safety
• Data management and data mining
• Safety & Risk Management
• Signal Detection
• Risk Management
• Benefit-Risk Assessment
• Safety Evaluation
• Regulatory Affairs, Pharmacovigilance
• PV Governance
• Safety Surveillance
• Pharmacovigilance Operations
• PV Inspection and Audit Readiness
• Patient Support Programs
• Market Research Programs
• Medical Safety
• Medical Information
• Pharmacoepidemiology