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PMS and Vigilance System

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PMS and Vigilance System

PMS and Vigilance System

Post Market Surveillance (PMS) and Vigilance are crucial aspects of regulatory oversight in the medical device and pharmaceutical industries. They involve monitoring the safety and performance of products after they have been placed on the market to identify and respond to any adverse events or issues that may arise.

Post Market Surveillance Medical Device

Post Market Surveillance refers to the systematic process of monitoring the performance and safety of medical devices or pharmaceutical products once they are available to patients and healthcare providers.

  • Detect and assess any adverse events or issues related to the product's safety or performance.
  • Evaluate the effectiveness of risk mitigation measures implemented during pre-market stages.
  • Collect data for ongoing product improvement and regulatory compliance.

PMS activities typically include

  • Collecting and analyzing data from various sources such as complaints, adverse event reports, clinical studies, and registries.
  • Conducting trend analysis to identify patterns or emerging issues.
  • Implementing corrective and preventive actions (CAPAs) based on findings to ensure product safety and effectiveness.

Vigilance

Vigilance is the process of monitoring and reporting adverse events associated with medical devices or pharmaceutical products to regulatory authorities. It involves the timely collection, assessment, and reporting of adverse events to ensure patient safety.

  • Prompt reporting of adverse events by manufacturers, healthcare professionals, and patients.
  • Assessment of reported events to determine their causality, severity, and potential impact on patient safety.
  • Communication of safety information and regulatory actions to stakeholders to mitigate risks.
  • Collaboration with regulatory authorities and other stakeholders to address safety concerns and implement necessary measures

Other Important terms

  1. MIR (Manufacturer Incident Report): A report submitted by the manufacturer to regulatory authorities when a serious incident involving a medical device occurs.
  2. FSCA (Field Safety Corrective Action): An action taken by the manufacturer to reduce a risk of death or serious health damage associated with the use of a medical device. It may include product recalls, design changes, or other corrective measures.
  3. SAE (Serious Adverse Event): A serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or causes significant disability.
  4. PSR (Periodic Safety Report): A comprehensive report submitted by the marketing authorization holder for pharmaceuticals, summarizing the safety profile of the product at defined intervals.
  5. PSUR (Periodic Safety Update Report): Similar to PSR but specific to medical devices, providing updates on the safety and performance of the device at predefined intervals.

 

Advancing Healthcare Through Innovation

How OMC Medical can help your Organisation with PMS and Vigilance?

  • Global Compliance Expertise: OMC Medical offers comprehensive knowledge of post-market surveillance requirements across various regions, ensuring clients remain compliant with international regulatory standards. 
  • Vigilance Strategy Development: OMC Medical collaborates with clients to develop robust post-market surveillance strategies tailored to their specific products and target markets. 
  • Adverse Event Reporting Guidance: OMC Medical provides guidance on adverse event reporting processes, facilitating timely and accurate submissions to regulatory authorities worldwide. 
  • Trend Analysis and Risk Assessment: OMC Medical conducts thorough trend analysis and risk assessments to identify potential safety issues and mitigate risks associated with marketed medical devices. 
  • Complaint Handling Support: OMC Medical assists clients in establishing effective complaint handling procedures, including investigation, documentation, and resolution, to address customer concerns and regulatory requirements. 
  • Regulatory Liaison Services: OMC Medical acts as a liaison between clients and regulatory agencies, facilitating communication and ensuring compliance with post-market surveillance regulations globally. 
  • Continuous Monitoring and Updates: OMC Medical stays abreast of regulatory changes and updates related to post-market surveillance, providing clients with timely insights and recommendations to adapt their strategies accordingly. 
  • Training and Education: OMC Medical offers training and educational programs to help clients understand post-market surveillance requirements and build internal capabilities for ongoing compliance. 
  • Audits and Inspections Preparation: OMC Medical assists clients in preparing for post-market surveillance audits and inspections, ensuring readiness and compliance with regulatory expectations. 
  • Continuous Improvement Initiatives: OMC Medical supports clients in implementing continuous improvement initiatives to enhance post-market surveillance processes and drive product quality and safety improvements.