Using Smart Tools for Post-Market Surveillance - Veronika Valdova
In this Case study, Veronika Valdova outlines her meticulous approach to conducting surveillance and vigilance activities related to regulatory affairs, focusing on a specific product known as citrate anticoagulation for hemodialysis.
She emphasises the importance of using standardised terminology and creating custom surveillance hubs to refine her searches effectively. By tailoring her search parameters, she ensures that the results are relevant and accurate, particularly when dealing with regulatory classifications that vary between regions, such as Europe and the United States.
Moreover, Veronika underscores the significance of understanding product specifications and risk management files to facilitate her surveillance efforts. She discusses the need for precise documentation and detail how Hoodin's platform aids in streamlining the surveillance process. The platform allows her to monitor a wide range of targeted sources with ease, ensuring that she stays informed about relevant developments in her field.
Ultimately, the conversation highlights Veronika's commitment to thoroughness and efficiency in regulatory surveillance, as well as the valuable role that Hoodin's platform plays in supporting her efforts.
Veronika Valdova's case study illustrates the transformative power of leveraging smart tools for post-market surveillance in regulatory affairs. By employing standardised terminology, custom hubs, and Hoodin's platform, Veronika effectively navigates complex regulatory landscapes, ensuring compliance and efficiency in her surveillance efforts. Her meticulous approach highlights the importance of understanding product specifications and risk management files, ultimately leading to informed decision-making and streamlined processes. Veronika's commitment to thoroughness and efficiency serves as a testament to the value of utilising smart tools in regulatory intelligence and product surveillance.
CASE STUDY
Name: Veronika Valdova
Profession: Medical device and drug safety consulting
Contact: LinkedIn
Challenges:
Keeping track of multiple sources for surveillance on global markets.
Documenting the activity of surveillance for post-market audits.
Solution:
Implemented Hoodin’s smart tools for post-market surveillance.
Utilising Report feature on Hoodin to document surveillance activity.
Results:
Successfully monitored all necessary sources for post-market surveillance.
Created comprehensive reports for audit documentation.