The following Key points in the elaboration of PSURs for Medicinal Products will be analysed in the present course:

• Comprehensive Safety Data Collection:
  From various sources, including clinical trials, post-marketing surveillance, literature, and spontaneous reports. The different source of information and quality of data retrieved will be analysed.
• Adverse Events and Reactions:
  Attendees will learn how perform a comprehensive analysis of adverse event, reactions as well as special populations (e.g., paediatrics, elderly) and information from vulnerable patient groups. How this can impact on the safety profile of the product involved.
• Signal Detection and Emerging Risks:
  How to perform a deep analysis of new safety signals or emerging risks based on available data.
• Risk Management Measures:
  How to evaluate the effectiveness of previously recommended risk minimization activities and how to discuss any risk minimization or risk management measures implemented.
• Benefit-Risk Assessment:
  The importance of evaluating the overall risk-benefit balance of the medicinal product and how to conduct a thorough benefit-risk assessment based on the collected safety data will be presented in this course.

Similarly, the key points this course will focus on related to the elaboration of PSURs for Medical Devices will be:

• Post-Market Surveillance Data:
  Sources for the collection of post-market surveillance data, including information from complaint handling, adverse event reporting, and other sources.
• Adverse Events and Device Failures:
  Details on how perform a comprehensive analysis of adverse events, including device failures, malfunctions, and any harm caused.
• Complaint Handling:
  How to describe in a PSUR the process for handling complaints related to the medical device and how to include an analysis of common complaints and their resolutions.
• Field Safety Corrective Actions (FSCA):
  How to report any FSCA initiated for the medical device and how to provide an assessment of the effectiveness of corrective actions taken.
• Emerging Risks and Signals:
  How to monitor for and report any emerging risks or signals in the post-marketing phase. How to perform a comprehensive analysis of potential risks and mitigating actions.
• Benefit-Risk Analysis:
  The importance of evaluating the overall risk-benefit balance of the medical device and how to assess whether the benefits continue to outweigh the risks.