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3 Case Studies: How to Use Smart Tools for Post-Market Surveillance and Regulatory Intelligence

Discover how industry leaders are leveraging smart tools to enhance post-market surveillance, regulatory intelligence, and product monitoring. Explore our case studies featuring Veronika Valdova, Martin King, and Marcus Emne, and learn how smart tools can help you overcome challenges and achieve remarkable results.

Case Studies Overview

Case Study 1: Veronika Valdova - Using Smart Tools for Post-Market Surveillance

Learn how Veronika Valdova, a medical device and drug safety consultant, successfully implemented Hoodin’s platform to streamline post-market surveillance and enhance compliance.

Case Study 2: Martin King - Smart Tools for Regulatory Intelligence

Discover how regulatory affairs and quality assurance expert Martin King used Hoodin’s platform to stay ahead of regulatory updates and maintain comprehensive surveillance.

 

Case Study 3: Marcus Emne - Applying AI for Product Surveillance

See how Marcus Emne, CEO of Hoodin, applied AI through Hoodin’s platform to set up effective product surveillance within the life sciences industry.

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Case Study 1: 

Using Smart Tools for Post-Market Surveillance - Veronika Valdova 

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.

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 2: 

Using Smart Tools for Regulatory intelligence - Martin King 

Name: Martin King

Profession: Regulatory affairs & Quality Assurance

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 and kept track of regulatory updates from various regulatory bodies.

In this case study, Martin King shares his experience using Hoodin for regulatory surveillance, particularly for his weekly regulatory roundup. He highlights the importance of Hoodin in capturing information from various regulatory bodies efficiently. Martin explains how he customises his searches using modules like "Regulatory Standards" and "Regulation Regulations" to filter relevant updates. By monitoring changes from regulatory bodies worldwide, Martin ensures he stays informed about critical developments. Martin demonstrates how he navigates Hoodin's interface, accessing information from multiple regulatory sources. He emphasises the platform's capability to provide real-time updates and streamline the process of regulatory monitoring. Martin's approach involves setting filters to focus on specific types of updates, such as regulatory changes or reports from authoritative bodies like the European Medicines Agency (EMA). Moreover, Martin discusses the practical applications of the information gathered through Hoodin, including populating his regulatory roundup and identifying competitor products. He stresses the time-saving benefits of using Hoodin compared to manual searches across numerous regulatory websites. Martin concludes by highlighting the versatility of Hoodin throughout the product lifecycle, from development to market withdrawal, and its role in enhancing efficiency in regulatory affairs. Overall, Martin's insights underscore the value of leveraging Hoodin's platform for comprehensive and efficient regulatory surveillance. Martin King's experience highlights the invaluable role of Hoodin in efficiently capturing regulatory updates from diverse sources. His adept navigation of the platform underscores its effectiveness in providing real-time updates and streamlining regulatory monitoring. Martin's insights emphasise Hoodin's time-saving benefits and its utility across the product lifecycle, making it an indispensable tool for regulatory affairs.

Case Study 3: 

Apply AI to set up surveillance for any product - Marcus Emne 

Name: Marcus Emne

Profession: CEO and founder of Hoodin SaaS platform

Contact: LinkedIn
 

Challenges:

  • Applying AI to setup compliant surveillance for a product.

Solution:

  • Implemented Hoodin’s AI feature to setup product surveillance.

Results:

  • Successfully set up surveillance for a product within the life sciences industry.

  • Established ongoing monitoring of necessary sources.

When setting up Hoodin, search queries are translated into various languages, ensuring that regulatory updates are retrieved no matter the publication language. For instance, if you need to create surveillance for medical devices, the system uses AI to assist in the setup process. This includes suggesting relevant indications, intended uses, and appropriate markets based on the product's lifecycle stage. The AI also helps identify similar products, enhancing the surveillance setup. When setting up the surveillance, the user can specify the regions, such as Europe or North America, where the product is sold. This is crucial as many regulatory bodies publish updates in non-English languages. Once the setup is complete, Hoodin translates all search queries to match these languages, ensuring comprehensive regulatory monitoring. One of the standout features of Hoodin is its AI-driven analysis of lengthy articles and regulatory documents. The AI generates concise summaries, helping users quickly determine the relevance of the content without having to read through extensive text. This feature is particularly useful for interpreting scientific journals and regulatory updates pertinent to the life sciences industry. By automating these tasks, Hoodin saves users significant time and ensures they stay informed about critical regulatory changes affecting their products.

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