Pharmacovigilance and Risk Management Strategies Conference

Monitoring of the safety of medicines has always been a top priority for life science companies, regulators, healthcare providers, and patients. The COVID-19 pandemic has created numerous challenges across the healthcare landscape, from patient access to care and the conduct of clinical trials, to data collection for clinical safety and post-market pharmacovigilance, to the need to adapt regulatory expectations to sustain critical care and research while protecting patients and the public.

For pharmacovigilance professionals, the complexity of safety and pharmacovigilance efforts is heightened by the rapid development of multiple vaccines and treatments, the emergent nature of knowledge about the etiology of the corona virus disease, and pervasive misinformation about prevention and treatment practices. The current challenges are ongoing and will have lasting impact on safety, pharmacovigilance, and risk management.

DIA's Pharmacovigilance and Risk Management Strategies Conference provides the foundation for strong strategic planning and practical decision-making in pharmacovigilance programs. Developed by recognized experts from the biopharmaceutical industry and global regulatory agencies, this conference provides the background, context, and opportunities to discuss current challenges and to problem-solve around issues that matter most to professionals working in the field.

For this year’s program, stakeholders from medicines research, global regulation, and healthcare will join together to analyze the challenges for safety and pharmacovigilance efforts in this uncertain environment and examine effective strategies for addressing gaps and needs. New approaches and collaborations that build on the foundation of sound pharmacovigilance principles to optimize safety and pharmacovigilance practice and ensure safe medicines for patients will be explored.

The program has been released! Preview all session descriptions, speakers, and more all in one place! View Program

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
  

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

• Describe the impact of innovative designs, rapidly moving development programs, and early authorizations for COVID-19 therapies and vaccines on safety monitoring, safety endpoints, and ongoing signal detection and risk management activities for these products
• Identify options for addressing potential data “gaps” caused by changes to routine data collection in response to the pandemic situation
• Identify approaches for measuring the effectiveness of risk management plans (RMPs) and risk evaluations and mitigation strategies (REMS)
• Discuss the regulatory landscape of safety surveillance for drug products including generics and biologics, including regulatory requirements related to COVID data collection and their wider impact on on post-marketing surveillance
• Describe the current landscape for pharmacovigilance regulation in Europe, including the upcoming work priorities for MHRA & EMA
• Gain awareness of potential issues for PV compliance and country-specific expectations for the conduct of pharmacovigilance in the Asia and Latin America regions and how they can be addressed
• Examine emerging strategies and tools for managing increasing volumes of safety-related data from multiple and new sources