Post-Market Surveillance and Real-World Evidence

Post-market surveillance (PMS) is a vital process that ensures the ongoing safety, performance, and effectiveness of medical devices and pharmaceutical products after they reach the market. As real-world use introduces variables not always captured in pre-market studies, PMS becomes essential for identifying emerging risks, managing adverse events, and driving product improvements. This training offers a practical, in-depth look into how companies can build and maintain robust PMS systems that meet FDA and international regulatory requirements.

Participants will learn how to implement surveillance programs that support compliance and protect patient safety. Topics include adverse event reporting, complaint handling, data analysis, risk assessment, and regulatory strategy. Real-world case studies and expert insights will highlight common challenges and proven solutions.

The session also emphasizes collaboration across functions—regulatory affairs, quality assurance, product management—and with external stakeholders, including regulators and healthcare professionals. Attendees will leave with actionable tools to navigate the complex post-market landscape, ensure regulatory readiness, and promote a culture of transparency, compliance, and continuous improvement. Whether launching a new product or managing one already on the market, this training will sharpen your PMS strategy and support long-term product success.

WHY YOU SHOULD ATTEND

An ineffective PMS system can turn hidden product issues into major regulatory, financial, or safety problems. This training gives you the tools to stay ahead—by monitoring product performance, identifying risks early, and ensuring full compliance with FDA and global regulations. You’ll learn how to handle complaints, analyze post-market data, and drive continuous improvement with confidence. Gain practical skills, avoid costly setbacks, and protect both patients and your brand—don’t miss this essential session.

AREAS COVERED

• Introduction to Post-Market Surveillance and Regulatory Frameworks (including FDA 21 CFR Part 820 and EU MDR)
• Adverse Event Reporting and Complaint Handling
• Market Analysis and Monitoring for Risk Trends
• Post-Approval Studies and Risk Assessment Methodologies
• Best Practices for Establishing PMS Systems (aligned with ISO 13485:2016 requirements)
• Case Studies of Effective PMS Implementations
• Ethical Considerations and Emerging Trends in PMS
• Collaboration with Healthcare Professionals, Regulators, and Manufacturers

WHO SHOULD ATTEND

• Regulatory Affairs Professionals
• Quality Assurance/Quality Control Managers
• Risk Management Specialists
• Product Managers
• Medical Affairs Professionals
• Pharmacovigilance and Safety Officers
• Compliance and Quality Management Professionals
• Clinical Research and Development Professionals
• Senior Executives and Decision-Makers

Course Director: MEREDITH CRABTREE

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.