Post-Market Surveillance and Real-World Evidence (RWE) - Enhancing Safety, Effectiveness, and Compliance

Overview:

Post-Market Surveillance (PMS) and Real-World Evidence (RWE) are central to modern quality and regulatory strategies for drugs, medical devices, and combination products. This webinar explains how PMS systems monitor product performance through complaints, adverse event reporting, safety signal detection, and risk management, in alignment with FDA, ISO 13485, and MDR expectations. Participants will explore how real-world data-drawn from electronic health records, registries, adverse event systems, and other sources-can be transformed into RWE that informs safety actions, labeling changes, and regulatory decisions. The session also addresses practical challenges, including data quality, interoperability, and privacy, and highlights how technology, analytics, and cross-functional collaboration can enhance post-market systems. Attendees will gain actionable steps to evaluate their current PMS/RWE programs, close gaps, and build a more proactive, compliant post-market quality management system

Why you should Attend:

If your PMS activities are limited to basic complaint handling and ad hoc adverse event reports, you may be missing critical safety signals that regulators can see before you do. Weak integration of RWE into your post-market system can lead to delayed responses, labeling gaps, audit observations, and loss of stakeholder trust. This webinar shows you how regulators expect PMS and RWE to work together, where programs commonly fall short, and what you must strengthen now to avoid surprises during FDA, ISO 13485, or MDR audits and inspections. 

Areas Covered in the Session:

• Overview of Post-Market Surveillance (PMS)
• • Definition and purpose of PMS
  • Role of PMS in maintaining safety and effectiveness
  • Core regulatory requirements (FDA, ISO 13485, MDR)
• Real-World Evidence (RWE) in Post-Market Surveillance
• • What is RWE and why it matters
  • Differences between clinical trial data and RWE
  • FDA’s increasing reliance on RWE for safety monitoring and decisions
• Challenges and Opportunities in RWE Integration
• • Data quality, consistency, and interoperability
  • Ethical and privacy considerations
  • Opportunities for faster signal detection and better effectiveness insights
• Regulatory Frameworks and Compliance
• • FDA guidance and expectations for RWE and PMS
  • ISO 13485 post-market surveillance requirements
  • Medical Device Reporting (MDR) and vigilance obligations
• Implementing Effective PMS Programs
• • Best practices for post-market quality systems
  • Data collection, trending, and safety signal detection
  • Adverse event reporting and complaint handling
  • Leveraging technology (AI, dashboards, analytics) for RWE
• Case Studies and Lessons Learned
• • Examples of successful PMS and RWE programs
  • How RWE has influenced recalls, field actions, and labeling updates
  • Practical takeaways to strengthen your own PMS and RWE strategy

Who Will Benefit:

• Regulatory Affairs Specialists / Managers / Directors
• Quality Assurance / Quality Control (QA/QC) Specialists / Managers / Directors
• Post-Market Surveillance Coordinators / Managers
• Pharmacovigilance and Safety Specialists / Managers
• Compliance Officers and Risk Management Professionals
• Clinical Affairs / Clinical Research Managers and Directors
• Product Safety Managers and Vigilance Officers
• Data Analytics Specialists working with healthcare or medical product data
• Operations and Product Lifecycle Managers