TOPRA Webinar

 Mitigating Risks Through Automation.

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Questions and answers from the webinar

Does Hoodin also cover RI for medical devices?


Yes, Hoodin provides an industry solution for Medtech and one of the Use Case templates is for Regulatory Intelligence. You may read more about that solution here.




Did you also include animal health regulatory sources?


Yes, Hoodin does support the ability to add all types of regulatory sources.




Can you demonstrate a regulatory guideline topic search e.g Nitrosamines


We´re sorry we didn't have time to show this during the webinar. Feel free to book a 30 min walk through with an expert from Hoodin here and you will receive a tailored demonstration of the platform.




How do you automate project management?


There are several ways automation could be added to project management and a great variety of tools available. By using tools such as monday.com, Podio or Trello you may add automation into some parts of the project process.




Have you noticed emerging solutions for storing those regulations?


Hoodin is a versatile platform where all content from a RI project may be exported to any third party storing software. Hence, we do not screen the market for storing solutions, but making sure that users may export content to store it any way they want.




Management tend to consider this part of a RA professional's job. How can one convince their Finance to consider investing in a solution/service given the ever increasing amount of regulations and updates?


The business case to set aside a rather small amount of money (Hoodin costs $129 per month) to make a process up to 90% mer efficient should be enough to convince any CFO. If that should be enough it is a good idea to mention the risks that the company faces if RI is not performed in an automated and systematic way.




Is your platform suitable for interfacing? Some companies have implemented RIM platforms and it may be a good idea to be able to link reg updates to regions, applications, individual submissions and even Health Authority communication to make those updates readily available.


Yes, there is an API available so that users may hook up Hoodin data to other services.




How do you monitor sources that are not in English? Is it done manually?


Sources in any language can be monitored via Hoodin. Some of the current Use Case templates include non-english sources and the only thing to keep in mind is that you need to create a separate monitoring feed on sources per language since matching words must be in the same language as the source.




Do you monitor social media? There is a number of "influencers" in the RA space that tend to share updates via Twitter including agencies.


Yes, one may monitor social media with Hoodin. Making sure to monitor those influencers you mention is getting more and more important.




Do you think that, as in other professions, increased automation puts people's jobs at risk since they eventually could be replaced by AI?


No, at least not in the next coming 10 years or so. A company's need for RI changes over time as the content, which makes it an automation that is not well suited to solve completely with AI. Our intention is to minimize the time consuming manual searches and move time and attention to business improvements and the actions required.




What is the timeline of delivering new updates?


Time line varies a bit per source and an average would be 45 minutes. The very first time a project is created it will however take a bit longer. Sometimes up to 24 hours.




How much time do you anticipate is saved when using automated monitoring vs manual?


According to our measurements, a company saves about 80 to 90 percent of the time, compared to manual and repeated searches / gathering of information.




Besides the source viewed in the presentation, what other sources should be monitored and do you have a list containing all sources one should monitor?


What sources to be monitored is unique per company. It depends on what markets you are on, what type of products and therapeutic area you are in. Hence, the sources of countries' legal authorities will differ, so will some literature sources do as well. This also states that it is impossible to provide a list of sources that would fit any company. Hoodin contains about 300 sources for RI and Pharma, plus social media. Besides, a user can add their own sources to monitor via Hoodin.




Companies are increasingly looking for in-house solutions to weed out the noise from the real changes and regulations that may impact them. Another problem is getting those updates to the right people on time, especially for companies operating in multiple regions. What are your recommendations to such companies?


A fully automated content monitoring using a platform such as Hoodin, has many advantages over semi-automated or manual content monitoring. One of these is the ability to help filter out results that are not relevant or required rapidly. Another is the ability to share the findings easily and quickly with team members or externally via reporting and sharing functionalities built into the platform.




Other departments, such as QA, tend to monitor the regulations in their area and in my experience they are not too excited about RA giving them updates. Thoughts?


With any good regulatory intelligence function it is important to gather, analyse and share the most relevant information to the right people and in a timely fashion. Full automation content monitoring platforms, such as Hoodin, allow the project manager for any content monitoring platform to carefully select what is monitored and who the results are shared with. This can help to ensure that colleagues only receive relevant updates.





 
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