The post-market phase of a product’s lifecycle is as crucial as its development and pre-market phases. Once a product reaches the market, its real-world performance, safety, and effectiveness must be closely monitored to meet regulatory requirements and ensure patient safety. Post Market Surveillance (PMS) and vigilance programs are essential tools in identifying potential risks, mitigating issues, and driving product improvements based on post-market data.

This comprehensive training provides participants with the skills and knowledge to design and implement effective PMS systems. Attendees will learn the fundamentals of adverse event reporting, complaint handling, and regulatory requirements. By analyzing real-world examples, participants will understand the importance of market analysis, post-approval studies, and risk assessment methodologies.

The session will cover key regulatory frameworks, including FDA and international guidelines, to help organizations align their practices with compliance requirements. Practical case studies will highlight successful PMS implementations and lessons learned from challenges faced by industry leaders. Participants will also explore how to collaborate with healthcare professionals, regulators, and manufacturers to strengthen surveillance systems and ensure transparency in reporting.

By the end of this training, attendees will have the tools to proactively manage risks, ensure product safety, and foster a culture of compliance and continuous improvement. Whether you’re in regulatory affairs, quality assurance, or product management, this session is a must-attend to enhance your post-market expertise and support your organization’s success.

Areas Covered

Who Should Attend    

Why Should You Attend

Are you prepared to manage the unknown risks lurking in your product’s post-market phase? Without an effective Post Market Surveillance system, hidden risks can escalate into serious issues such as regulatory violations, product recalls, or compromised patient safety. Fear of non-compliance and the complexities of regulatory requirements can paralyze organizations, leaving them vulnerable to costly consequences and reputational damage.

This training equips participants with the tools and knowledge to proactively monitor product performance, ensure regulatory compliance, and mitigate risks. You will learn how to leverage post-market data to identify adverse events, handle complaints efficiently, and drive product improvements. Gain confidence in navigating FDA and international regulations while mastering strategies for risk assessment and reporting.

Don’t let the fear of non-compliance or uncertainty around post-market data hold your organization back. With expert guidance and actionable insights, this session empowers you to take charge of your post-market surveillance activities and establish a culture of continuous improvement. Step ahead of challenges, ensure product safety, and build consumer trust—join this training and unlock the potential of effective post-market vigilance.

Topic Background    

Post-market surveillance (PMS) is a critical process in ensuring the safety, performance, and effectiveness of marketed products. For regulated industries such as pharmaceuticals and medical devices, PMS helps monitor product use in real-world settings, identify potential risks, and address them proactively. This training provides a comprehensive overview of PMS, emphasizing regulatory requirements, risk management strategies, and continuous improvement initiatives. Participants will learn how to implement effective surveillance systems, handle adverse event reporting, and utilize data-driven decision-making to maintain compliance and safeguard public health. With real-world examples and best practices, this session equips professionals with the skills to navigate the complexities of post-market surveillance and drive organizational success.