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  • Writer's pictureTeam Hoodin

AI and Smart Tools for Enhanced Surveillance

Updated: May 20

Welcome to the Hoodin RAQA Deep Dive Sessions blog post! In this edition, we'll explore insights from our recent special edition webinar where we met with leading regulatory experts Martin King and Veronika Valdova to discuss the role of AI and smart tools for surveillance and vigilance.


Theme: "AI and Smart Tools for Enhanced Surveillance"


Guest speakers: Veronika Valdova & Martin King


Further down in this blog post, you will find a summary, Q&A, and other useful assets and resources.


Watch the recorded version of the webinar 


🎙️ Speakers:  Veronika Valdova & Martin King

📚 Theme: AI and Smart Tools for Enhanced Surveillance

🗓️ When: May 16, 4pm CET / 11am EST

⏱️ Duration: 48 minutes



Summary:

The regulatory landscape in life sciences is becoming increasingly complex due to:


  1. Diverse Regulatory Requirements: Companies must comply with varying regulations in different countries, each with its own set of standards and submission formats.

  2. Frequent Updates: Regulatory guidelines are frequently updated to keep pace with scientific advancements and emerging health threats.

  3. Data Volume and Management: The volume of data required for regulatory submissions is immense, including clinical trial data, manufacturing processes, and post-market surveillance.


This complexity can lead to significant challenges:


  • Risk of Non-Compliance: Non-compliance can result in severe penalties, product recalls, and damage to a company’s reputation.

  • Resource Drain: The traditional methods of managing regulatory affairs are resource-intensive, requiring significant time and manpower.


The Role of AI and Smart Tools:

To address these challenges, the life sciences industry must embrace AI and smart tools. Here’s how these technologies can transform regulatory affairs:


  1. Efficient Data Management: AI can streamline the collection, analysis, and submission of regulatory data, reducing the burden on regulatory teams.

  2. Predictive Analytics: AI-driven tools can predict regulatory trends and potential compliance issues, allowing companies to proactively address them.

  3. Automated Monitoring: Continuous monitoring of regulatory changes globally ensures that companies remain compliant without the need for extensive manual oversight.

  4. Enhanced Accuracy: Machine learning algorithms can enhance the accuracy of regulatory submissions, minimizing the risk of human error.



Q&A and Assets:


Can this AI automatically translate stuff? YES!

From multiple sources? YES!!


Can Hoodin 360 help in updating the CER for your device? 

Yes, and that is exactly what it is designed for. Take the free trial, test one of your products and you will experience automation of CER updates!


Can the tool translate the scanned pdfs too - especially from China sources and other Asian countries? 

Yes. The Hoodin system can even read scanned photos of documents and translate a summary of its text. 


How do you maintain confidentiality?

We maintain confidentiality through strict data protection measures and adherence to our comprehensive privacy policy. For more details, please refer to our Privacy Policy. https://www.hoodin.com/privacypolicy


What about monitoring PMS indicators and their thresholds?

 Similar as for the question regarding update of CER. The concept 360° Surveillance and Vigilance cover all you need to reach compliance for your PMS in regards to retrieving public data.


Nice presentation, what is the cost of Hoodin? 

€139 per month. See current price list here: https://www.hoodin.com/pricing


Can you set it up to do monthly literature searches to update your PSUR? More than so, you have real time updates, all the time. Then you simply select a month or any given time period and create a report.


How is Hoodin 360 different from Nyqvist AI?

We have not tried the solution from Nyqvist lately. It seems to be a very fine solution and rather similar to Hoodin. Nyqvist stands out by incorporating many graphic elements, such as data maps, which serve as an excellent initial guide. However, the true value lies in how you can utilise this data in your reports. At Hoodin, we focus on maximising this potential. Pricing also differs. Hoodin is about a quarter of the price of Nyqvist. The best approach is to take advantage of the free trials offered by both products to determine which one meets your requirements.



Contact Expert Speakers:





Haven't explored AI and smart tools for regulatory affairs yet? Try Hoodin with a 14-day free trial. No credit card required, and it only takes about 15 minutes to see how it can enhance your compliance and surveillance efforts.




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