EU MDR & IVDR Vigilance Expert Workshop

Hello, welcome everyone to Em. EE. Mdr. And Ivr. Vigilance workshop. This expert workshop is presented by mid tech leading voice and sponsored by couldn't generously thank you very much for joining us. I can see everybody entering as I speak. So I'm gonna speak really slowly. To give everybody a chance to enter Veronica. If you wanna advance to the next slide. Getting the ball rolling I wanna mention. And I'm gonna mention this couple of times throughout. I'll use the chat and Qa. Functions throughout the call. Go ahead and test them if you want and you can submit questions at any time. And use the chat function as well.

Again, a recording will be available to everyone, and the slides will be made available from Veronica upon request. we're going to do brief introductions. There's going to be a couple a few poll questions throughout afterwards. There's a survey which I implore you implore you to complete, to help. couldn't understand where you're coming from and what your needs are regarding vigilance and post market surveillance. This is really important, and you, if you have any other questions, please feel free to contact me. Lastly, there's another Mlv. Webinar tomorrow on Eastar, and one the following week on global paths to market. I'm gonna put both of those in the chat

with registration links as well. I think that it for me. If you wanna start with the next slide, Veronica, I think we're ready. So Veronica awesome to have you here today. Thank you for having me. Please tell us a little bit about your experience with vigilance and and and about you.

Well, I'm I spend most of my life in a drug safety, even though I'm a veterinarian by education. And in about 2,013 I moved on to devices where I started at a a check drug agency where I dealt with vigilance and field safety correctly. Options. And the I have been dealing with this kind of clinical evaluations of medical devices transition to Mdr. And post market safety, surveillance and vigilance for a number of years now, and all, all the challenges that I will I will be talking about are my direct experience. I believe that Hooden is a game changer in a post market service and vigilance, and it has to put into to save enormous amount of time and anguish. For people in the industry.

Marcus, why don't you introduce yourself briefly, and say hello to everyone.

Yes, thank you very much, and and glad to be here. Well, my name is Marcus. I'm now. I'm the founder and CEO of hooding. and just a little bit of of the reasons why Huden once was founded. Was some or well, we really really wanted to to solve the the struggles and the problems that occur when you need to monitor a a huge amount of information, and and compile that into material used for decision making for life science industries. My eldest daughter had a knee surgery where one of the titanium screws, or both of the titanium screws were contaminated, and I tried, as a father to do what I could to prevent any other family and kid to experience this situation with no luck.

and that's when I realized that Hooden Barfetch from that event. But that hooding could help the manufacturers with patient safety and do the job related to post market surveillance and vigilance much more safer and much more effective. And well, that's the long story short, really, and that's where we are right now. With our hopes and beliefs to make life easier, and to make post-market surveillance and vigilance a smooth and and qualitative process. we have as a sponsor of this masterclass presented a unique offer for anyone who participates. I think you will

really like it, because it's very unique for you as an as a participant today, and we're gonna present it at the end of the master class. I certainly advice you to to stay with us throughout the entire class. Last thing I'm I'm based in Sweden Sound, part of Sweden, near a town called Malmo, which is just at the border of Denmark, so I can. I can see Copenhagen if I watch out here. And speaking of that. we can move on to the next slide. A chat question, where are you from? It would be nice to get to know each other a little bit. Shawn is from Philly.

Yes, and somebody wrote in that the chat function is disabled so you can use the QA. Function if the chat function isn't working for you, although I don't really understand why it's disabled. Because I I'll try to figure that out and so you can use the QA. To say where you're from. Huh? Thanks. That seems to be working.

Yes.

So calling from Turkey, Tunisia, Uk, San Francisco, Orange, California, Edina, Uk, Hebron, Kentucky, Lyon, France. Uk, right, all over the world. It's Germany, Ireland, Othamona India.

I noticed that was a very internal joke between me and the participant from Gutenberg.

so thank you for for entering that Belgium, Portugal, Stockholm everywhere, I mean, I'm just thrilling to see all the people coming from all over the world to this event. I just it warms my little heart. Thank you for sharing where you're from. So let's talk about why, we're here, Veronica, let's talk about the challenges of post-market vigilance.

Well, the challenges, you know, post marketing, post-market surveillance of medical devices are numerous, and some of them are deadly. That European medical device regulation introduced requirements that cannot really be in easily satisfied. Moreover, these requirements are continuously evolving as new Mdc. Guidelines are published. Multiple national databases exist that must be screened for advisory notices, field safety, corrective actions. 3 calls. Not only concerning your own product, but also equivalent as declared. And similar products. If yeah, if you perform periodic review of data that is required to support both market surveillance activities of

medical device for recertification. It's very time consuming, as you probably know. and most manufacturers still rely on a manual efforts to do this job. but in insanely expensive when you count all the hours that you need to spend on it.

Unlike medicinal product, events and incidents are not publicly available in Europe.

You can get some of them in a in the Us. And in our overseas databases like Canada or Australia. Here, whatever comes from Europe typically would end up for the same product, or often in similar product in in the US. And all the other countries. And the manufacturer would only learn about it from overseas databases or through field safety corrective action. because the other information simply isn't available. When you when you go through the first challenge. That means getting all the data in house. Then, handling all this information is yet another challenge.

The procedures for Pms. Applications are defined in Mdr. In in the new regulation. And one of the trick requirements is that the plan should allow correct characterization of the performance of devices. that are similar to your product. So you you not only have to monitor products that are yours. You only need you also have to monitor products that are similar in in the same category the same, the same class, and be able to pick up information about the other people's products that is not necessarily available in the databases that are currently available through the National Company.

This list is not exhaustive. It's a just a sample it's a continuously evolving. And II forgot to include device specific vigilant guidelines. Which? include additional layer of requirements for operation. pacemakers, best implants and some other specialized products so the requirements are very complex, con continuously evolving and very satisfied. What is your experience with post market survey on individuals and the procedures and the requirements, and the way the job is done in your organisation.

They have a poll question, so we can answer as you as you wish.

filling out the poll question. Veronica you know, thinking about vigilance and thinking about the challenges of vigilance. And all the all the places where you go to look for information. What would you say is the most helpful resource for finding information.

Well, when when I got introduced to Jurin, it really made my life so much easier it. makes it possible to set up the individual data feeds and check them regularly which in itself covers about about space. Otherwise. So I rely on. Us databases quite a bit. Because that's the only place where III get the information on both adverse event, adverse incidents and fields. Corrective actions, like advisory notices and recalls

each of them reside in a different database, but it still is the most helpful resource. and the Canadian one is a little more specialized. You you need a database person and download the data to be able to utilize it. Oh.

and and clean. It's a little bit fishy to use the Canadian one. Yeah, it's a it's ready. But the information in there is excellent

into it is is definitely a challenge. From the Europe advance. I actually like to check one. Because it's more or less filterable. It's one of the modern ones without the all the legacy baggage of the old systems. Is it searchable in English. Yes, it is actually and it's it's by by no means perfect. You cannot. Search by Gmd and a code you cannot search by product categories. But all the information is downloadable. filterable in excel. And then it's it's workable. Obviously, it's smaller country, and it's not possible to find all product in there.

But it's a good start compared to Swiss marik the French website. The Germans, you you cannot really find from like, everything is in Pdf, and it's not comfortable. And you can organize the information in any way, shape or form so with the. It's very challenging to go through it.

So I'm gonna share the poll results. 14% said, it's their main activity. 31% said that they perform Pms and other duties. 23. They have some experience, and 2% says, I have little experience. And then 31% says, I have minimal or no experience with Pms, so a broad range of experience levels. Thank you. All, for sharing just stop sharing that and and we can. We can move on.

This is a handout so feel free to explore. All all the information provided. This is the information that our manufacturers must submit to individual national competent authorities. Because functional, you wouldn't find information in there it still goes through. You know the old procedures so it's in the position of the National Company and authorities, and then a share. The 2 key components are adverse incidents and field safety corrective options and as a result of a field safety corrective option. You can just be good. A field safety note is of some kind. It can be, I think, of laboring. It can be a request to

and repair refurbish modify product, or some additional training or it can be a recall. So it's very generic. So other manufacturer must notify all their customers. In a form of field safety notice this is very challenging, because the procurement departments that generally deal with distributors when purchasing the product are not necessarily the ones who are dealing with any kind of safety options. That would be the hospital risk manager, or supply chain manager, or a a additional functions.

And it also depends on type of organization where it goes. So this conduct is very important. And very often hospital hospital staff would rely on official sources rather than the individual manufacturers to manage their safety notices. So Hooden might be actually a huge resource for this hospital environment as well. It's a important to note that a manufacturer would not necessarily be aware of. many of those safety safety issues concerning equivalent and similar devices, because it's confidential to them.

So when a manufacturer of a incident pumped or something similar sends a serious event to a duck agency than the national competent outdoor id may pass it on if it for if it meets this kind of criteria and it it's likely to lead to unanticipated public health bread so then, they circulated through their internal system. And then they notify the manufacturers. Who might be affected by this. It's generally useful to be aware of this kind of issues in advance. So it doesn't come as a complete surprise.

So what's your responsibility, Bevina? Post market surveillance and visual ones? Question.

sorry, I'm trying to

holes.

It's gonna be a tricky poll with that silent drama going on. Sorry. Sorry I'm trying to figure out how to use. Did? Did did all the poll questions get launched simultaneously. Is that what happened? I'm not exactly. Yeah. II think we we took care of all question number 2. All of them came up in once.

Oh, okay. so that's convenient. So the answer to the poll question that everybody submitted. Was

good.

Right?

I think we can go back to that and summarize the the poll questions. I'll do that at the end. Yeah. Sorry

the current situation is that you don't post market surveillance and vigilance model, it's not it available. And here I've got the way. Too many national databases to include UEUE. Iceland, Norway, Lichtenstein, and Switzerland. Each of them has their own. and each of them is designed completely differently. that's why the big markets in the Us. Canada, Australia and the Uk. Are used as a proxy, because, most products most medical devices are marketed in more than one territory, and if they are in Europe, they are typically also in one of these territories. So it's generally easier to find information about the

the device, you know, these databases than trying to find it in in Europe. field safety, corrective actions and recalls and safety announcements are available in some national registries, not all of them. And it's not always conveniently organized. Moreover, of information on adverse incidents in Europe is effectively non existent welcome to Udomet. It's a it's a beautiful, expensive database by European standards. I'm sure it's fantastic on paper.

but there's no no module. That which ones folks would be able to use. You cannot find field safety corrective actions in there. No recalls other incidents are not available no trends. So it's at this point you are not going to find anything anything of substance, you know. You don't. which lead us to worry of, you must do to be able to collect the information that you are legally obligated to collect. And that is so for adverse incidents on your product. That would be direct direct access, because that's all. Where the healthcare professionals and user users would report it. They would send it to you

or if if they send it to the regulator the regulator would forward it to you. So you get access to those the same with field safety corrective options. Where? It's a item mandated by agency, or it's originated by the manufacturer. So you would know about those the same with 3 calls but if equivalent and similar products it's a lot more difficult because you know European databases you wouldn't be able to find incidents you can go by Brooks if you overseas databases and some field safety corrective options and recalls would be available in on national competent authorities, websites.

not all of them, and not always ideally usable. which brings us to all the information that can be found, organized, collected, and utilized to put in back to you, Marcus.

Thank you. So, as I said, when I introduced myself, our our task is really to make this really cumbersome job with finding all of these sources where the where, where your product or competitive predicate devices. are being mentioned to speak listening language lingo lingo public. You publish publicly available information which could be great literature. It could be mentioned in in of your product or competitive products. In a a vigilant manner. Social media forums, and so forth. It's a big task to know what there's those

sources are, and it's a a very challenging task to find them to find the exact information. That's what Hooden does to that in mind where you should look for information and fetch it for you. Scientifical journals as well, including contains more than 250 journals and databases, including such as pubmed science direct, Cochrane, and so forth. Everything that is required to to reach compliance. We make sure that you get vigilance and surveillance upon by your superintendent. yeah, and that leads us to

what what we're Ronnie has been talking about is what is needed to be done. And IS. I'd say that I've talked just last year I counted to more than 250 different regulatory affairs and quality assurance people regarding this. and they struggle with both what to do and how to do it. and I just wanted to take the opportunity to to reveal and provide you with with my experience on how to deal with surveillance and vigilance. I bet you know the difference between surveillance and vigilance. Vigilante, which is the Latin word that vigilance derives from is is is mean. It means really stay awake.

And be alert. Surveillance is the ongoing process, right? But as it's a thin line. so oh, oh, sorry! Could you stay on that one first? If you hop back so one way of dealing with with surveillance and vigilance would be the manual way. the way you probably done it before. The tool you use would be a browser. The prose with this is that it's free. really. Besides the cost of your salary at your employee, the cons. it's a large number of sources that needs to be located, and they change over time, especially if you think about potential advertisements that occurs in social media and forums.

and they becoming more and more important, there's a considerable number of results to be filtered, reviewed from various locations, and you need to collect not only the article per se. You need to collect the timestamp when you did the search, the URL, and so forth. You've been there. You don't that you know how it is? It's a collection and and dissemination of results, not in one place which could make it a little bit of a hustle, resource, intensive, ineffective, reactive, and not systematic. And that is important. If you remember what is mentioned in in or described how you should set up your process according to Mdr.

so that's the manual way you can do it, but it is very time consuming, and it's there are risks involved this, the other approach that you can take on next, please. which I will call a semi automation way. Now, you could start to set up Google alerts. You can have email subscription news, news, newsletters and also make use of Rss. Feeds. This is a good start. If you haven't thought about automations at all, and have no money or or budget for for more advanced tools. This could be one way to get started. Still, it's free of use. and it will bring you some time saving over the manual content monitoring.

But again. the same problem remains. As for manual, you need to know where to look. and you need to take care of all these. yeah, all of the data in a structured way from these, Rss feeds from Google alerts and so forth. and it will acquire a lot of resource and time from you. It's it's also the 1 one con that isn't mentioned here is that the it's different formats and and that could really add on to the risk of making mistakes. So be careful when walking this path. It's fully doable, absolutely, and you should design an architecture for this. If you go this this road along.

and the the third way. would be full automation. There are other tools than Hoodin that could do partly what hooding can do. I'm not going to really reveal what those are to day. But there's a lot of wins with this. There's a lot of pros of going this way. All the sources needed would be there already. You don't have to figure that out on your own. All the results. They will be in the one and same place, and you can share this with colleagues and peers for commenting, and and get that dialogue on which is good, because then you involve peers, and you know, that will make the results more qualitative.

It's a 24 7 solution. So you never have to remember yourself to go in and make those researches. So all in all saves you a lot of time and minimize the risks of missing important information. There is a cost involved, a license fee, and there might be some training required. If you are not familiar with using online tools like this.

Marcus, II need to interrupt you and say that. Yes, there is a cost involved. But it's minimal in comparison to the competitor products that are available on the market.

Thank you for saying that II didn't want to mention it. II thought that someone else could do that. But yes, we. We believe that this this should be available to anyone the smaller start up that does not yet have a product on the market, and needs to figure out what are my applicable regulations and directives applicable standards vigilance reports on predicate devices, and so on without going bankruptcy. And and you could leave anytime. No one or 2 year subscriptions and and hundreds of thousands of of dollars involved. It's a €139 or dollar a month, and you could leave whenever you wanna

and we have so far had Sarah that left

great. Well, II can imagine why there's the amount of time that anybody needs to spend on this when it's done monthly is vastly higher than with. What do you need to spend on a this kind of tool?

Yeah, we also hit. We also hit the delete project buttons impossible to find.

No thanks. So how how to how to go about the searching multi-statabases? when you do not have any tools. and how it can be done, how it can be enhanced when you have the proper tool to do the job. Answered a pole question.

answered all the poll questions. Oh, okay. You already answered all the poll questions.

May I just review Veronica? Sorry. I think we have time. I'm I'm just came to think of one side effect as well. I spoke to. It was a Swedish company. I think it was Melnick healthcare and what they mentioned as a, as a, you know, side effect, a positive side effect, or or soft value from from applying a very systematic approach was that once and for all the the peers and other parts of the organization looked upon regulatory affairs, the regulatory affairs team as a cool and innovative team with AI driven platform that would provide

the surveillance and vigilance job in the in the cool manner that. you know, made others interested in what's going on and how they do it.

Wow! That's a that's a innovation factor. That's very nice. Ii can. I can imagine one of the benefits of doing it this way and that is auditability. And it's easy to record easy easy to keep track of who's been done it's very easy to show auditors with. The what kind of activities you you are engaged in. When you are doing all these activities manually. It's it's difficult to keep track, and it's difficult to prove that it was actually done. If the results are negative. 50 overseas database databases. Well, that's where I usually start now.

None of them is perfect but recovery is significantly better than than would you find in Europe. So it's generally a good starting point. if if there is an issue with a specific type of product, you would find it here. So you know, in the Us. We have got 3 different one for adverse incidents it's searchable by product code which is a good differentiator. It's not. I didn't go to Gmd. Annap, but it's a practical and off. So you can. You can correctly identify a decent subset of devices. Wherefore. at Udomat that is organized by emdens that is not logically into dirty usable selection.

So the organization, vip codes is something that I find as a great highlight of these databases. the Canadian one of. and so a little more difficult to use but the information inside is excellent. It it requires a database person to handle the information Australian one it's a lovely information is great, but every everything comes in Pdfs, and it's generally for finding and downloading auto Pdfs, one by one that's not very helpful.

And the the that's the same thing. It's it's very difficult to filter this search function is pretty poor. Now again, you only get Pdfs it's it's portable in excel which is a huge benefit

so you can make some sort of Anna, then play with the rest of it later. The information. May I may yet, could you hop back to the last slide. I just wanted to comment one thing. This might sound very selfish, but II want to point this out that what you see in top of these. Of these? a screenshot. 500 records meeting your search, criteria returned. This is not very unusual right? And the problem with that. This is a limitation of MoD, when you when you search on their website and the problem with that is that they ask you to narrow down your search, which is the timeframe

and then you have to figure out where you you know you hit the number 499, and remember that date, and then do it all over all over again, and 9 out of 10 that I've spoken to has realized that they get duplicates when they try to narrow down the time frame which screws the data set and then they get lost and and it's more or less impossible to figure out what the duplicates were. even worse, they send that off to to the auditor. Yeah, the good thing with using a tool is that it doesn't necessarily have to be. Hoodin could be any other tool. But we've been granted access to the databases of FDA. So when Hoodin searches

we have no limitations in number of records. so it could be 10,000, and we know exactly the date. Then what kind of adverse event it was you got it sorted in a in a different structure. I just saw that pain, and I wanted to comment upon it. Sorry to interrupt.

No, this is fantastic, because, there, there's a huge benefit Anna, just going into the state of braces who are wooden already. The the information is general generally usable. It's a logically organized logically. Step third. if total product life cycle it. It takes multiple steps to get to the information that you need. First, you need to select the product, then, yeah, you actually get to the list of issues. And yeah, need to narrow it down. So it's a it's not so easy to work with but information in the database is excellent. Recalls are provided separately, and those are a little bit harder to navigate

both. They come in this formal but fortunately they are also exportable in excel so organized and by the company, and also wider product Canada. Not not ideally searchable owner on their website comes in database full month. and Australia and again very time consuming to go through it. And manually. this is the output print version of this report. That's what you get. That's very difficult to deal with when you have got a hundred of them and need to process them meaningfully.

It doesn't give you any guile for usable export. Just the Pdf. Before the amateur. You have them nicely organized by date as they arise. So if you click on the date range, then you only see. What would that product? That is? That's not necessarily obvious. So where the product belongs. and only in the Pdf, you have. refer information. So it's not it's not logically organized, you know, any way, shape or form with the other European databases. Here I would highlight the check one

as a very useful one. And the the rest is a a nice sample of what you get. Houdini, has access to the farm, and which I believe is a great setting point, would you like to elaborate on that one?

Yeah, yeah, we we we treat vigilance in 2 ways, really, with 2 techniques one that is suitable for devices that have high amount of sold products, or, you know, high high volume products on the market, where the number of adverse events might be thousands on a year. That's when we look for the data and you aggregate it in into spreadsheets. However, we can only do that on databases with structured data such as b-form and MoD, and mh, ra, and FDA recalls.

those are tweetable. The others those we can, you can put vigilance upon via hooding as well while you would do it on article by article. So whenever your product is being mentioned by Estonia, France, Spain, Ireland, and so forth. You will retrieve that information, inform a one article which is not handled. You know it's not manageable. If it's tens of thousands of article that's when you needed the data spreadsheet. But for knowing that your number of adverse events might not be very many over a year, then the other way is much more suitable. Because it's wider.

And unfortunately that is a limitation. But that is the the best way so far.

I have a few examples of these databases the Germans like incidents essay. So device deficiencies and recalls. But they're not giving anything back only sponsors and persons obligated to notify have the option to enter and edit their data. And there is some public access. But it's a very limited to in in regards to what they give you access to. It doesn't include incidents. And actually, you do not even get Field City corrective actions this way. And it's paid. Because our intellectual property belongs to before.

This is probably the most useful one. Because it's one of the modern databases. They're they're built from scratch there was nothing before. and it doesn't have to deal with any kind of polygamy system fuel, safety corrective options can be filtered by device and manufacturer and date published. and you get them typically in a local language and language. Of course, it only gives you gives you access to whatever is on the local market. But that's the case of all these databases the interesting part is open data so a lot of the information is downloadable and useful for months.

You know, Denmark. you know, they organize the information by product type but a. The terminology the hierarchy is not aligned with any of the major dictionaries and type of security message, which is the draw, change, modification, design, change. process, change. Utreon stepped in, which really doesn't align with anything else.

It's very interesting that they implemented the feature so that you may share your field safety corrective activities on Facebook. If you want. Yeah, that's lovely. That's that's very interesting.

Yeah, we had a very interesting question from the audience, can you remark on the use of Imdrf medical terminology?

Is it necessary to use them? The Mdc. Guide, Psr. Suggests as much. Well, you know anything that Mdc. Suggests. Is going to be embraced by the notified bodies more or less and so that would certainly be advisable. But I would caution everyone that the Imdrf medical terminology is not going to be consistent across the databases as Veronica just mentioned. Oh, it won't, because

yeah. Well, you're not first. You are not going to get this information also, Anna. The field safety notices. They do not have to use it. And historically, it wasn't there. So what do you find on these websites is a wide variety of information at the searching for peace terms. It's it's not going to solve the problem fully met. Madra is metrics for drugs is omnipresent everywhere. Everybody uses it. That's the standard one bondwith. I'm d rf. you. You definitely will come across auto descriptions and event description. Anna.

the FDA databases, all of you is so free text it that. There's no no reference to some actual term. So no, they just wouldn't help searching for the actual imdr, if them. This is the typical format that you get in most of these databases that is organized by date when it arrived. and some sort of more or less standardized file name and Pdf. and that's it. Baseball. the French of

there's visual reports that is for the actual reporter, so they can find their own report. And consult the progress of the incident they reported. That's not to search for somebody else's the a database is organized somewhat logically. It's a drugs and devices, you know, one one database you have got kind type of product data type of safety information, which is a quality defect information for users or recall. And then type of a product and date range.

it's it's dogged but you still need to go through enormous amount of records to find what you need the same with Spain. It's organized by date. So you, you would have to monitor the entire website to find what you need and have have some way how to save the information on a regular basis internally, where you can deal with it otherwise. This is not searchable in a any useful way. Island as as you can see the organization of or the terminology differs from one database to another.

So we've got the third party publications warning record when you compare it to the French one, the Danish one each of them uses a different structure of the database. So it it's not necessarily helpful. You basically need a different procedure for each of these databases to satisfy your information requirements again. You need to click on the record to get the Pdf with the actual information that you need. And this is Hoodin, and I am handing it over to Marcus with Joey.

Okay, thank you. And I also see that we're running short on time. This is. This is a screenshot of you from from Hooden, where you apply will call database or historical vigilance it could bring. Bring you information that is up to 5 years old, and the selection of database here bases here, or sources would be be farm. Mhra recalls, and MoD that's where you go for the the high volume data. And it's being generated in in spreadsheets. And Pdf, if you prefer that so that you can copy that into your to your report templates or formats as you wish. That's one way of doing it the other way. Would be more of

as I mentioned earlier on the where you monitor more or less, all of these sources that Veronica has went through today. But you receive the the hits from the search or the monitoring us unique articles with links to the original article with timestamp. and so forth. So you you have it exactly as the notified body would prefer to see it. It would been great to have time to show you more of of the interface of hooding and what it can do for you. This is vigilance when it comes to the what's the next slide? By the way, is that still? Me?

Yeah, that's still you. Still, you that's that's the special offer.

Yeah, the special offer. Good. We're not done yet, so don't leave you wanna hear this? and and we can stay on this slide for a little bit more time. So some of the the obstacles and issues that we try to solve with within is handling a huge amount of data in a structured way, so that you get it in format, that you you want it, and that you how you can handle it for vigilance. That's one thing when it comes on the vigilance and surveillance part, such as the literature social media forums. You know, where patient discuss your device, or predict devices or similar devices.

And grey medium. On that side where we look for the entire article is being processed by AI. So if this is from, let's say, Finland, and you happen to not know Finnish very well, just a tough language. If you're not finished, then it's easy and and what the AI does is that it translates it. So you will get it in English. and you can add that as in the the summary and the translation of that as a comment to the original article, which is very helpful when you create the report, same thing goes with literature. All the Literature research is done automatically, and the AI creates a summary of the article which is very helpful, and translation, if it's non English

and long enough same thing with every source. Actually. we're not seeing that view now. This is for the vigilance of the databases and the high volume of potential adverse events. This, this is when you use this particular view. So let's move on to the next slide, then. And we would like to offer you as sponsors now is. The free trial. Training on how to use this? It's not much required. One should know that running a free trial of Hoodin is is not like setting aside a few days to learn a very advanced tool. I bet, and I challenge you that you would need more no more than Max. 2 h under this 14 free 14 day! Free trial to get your arms around Hooden. It's really designed to make this

giant herbal data thing as easy as possible. We will provide you with a free review of the first report. And this is unique of this is very, very unique for you. We can hop on to the next slide. So how to grab this exclusive opportunity bring up your phones screen the QR code. We will send you the the link. Exactly, Shawn. That's how you do it. And sign up for free trial. so start your free trial before the end of of February, via the the link that is generated by this QR. Code. We will send you the link as well.

During the free trial you have full access to the support, if you have any questions, and you will also, and we highly recommend you to do this sign up for an expert project. Review, so you will meet up with could be me could be someone else that put in that will review your project to make sure that you have really gotten what you need. And here comes the unique thing. Once you've activated your licence, you will get a voucher for compliance, assurance which means more or less call a friend that will walk you through a 7 step, compliance, assurance, so that you can feel safe and happy for running any audit, and that friend of yours is no other than

Veronica. so she will. Become your compliance, best friend. Helping you out, making sure that you can sleep well the the night before you have an audit, or sending off reports to to management the board eye directors and feel very safe about that. And that's completely unique for you guys. that's an add-on cost otherwise. But you will get that for free good. Now I really recommend you to do so. II think you will enjoy it. I'm not doing. I'm not saying that to sell really I

I think you will like it and have fun. Anything else I should or should not say sure. When I see that, you know. Let's wind it up. Let's I just wanna thank both of you very much. For your participation today. This has been

highly informative. I've already received a number of comments. Thanking us for the presentation a couple of questions about the presentation. we will. Email it to you. If you would like, and so included in the follow up email will be a link to download this as well as 2 appendices. Which are quite extensive. So I encourage you to do that and as I put in the chat, there are 2 more webinars, one tomorrow and one next week that I hope that you will attend and finally, I would just like to thank all of you for attending this special workshop. I hope you found it useful. Please please complete the survey which will be emailed to you, following the call. Thanks very much and have a day. Yes.

yes, we have had a tremendous amount of really great questions that we haven't had time to answer on during today. Would it be okay. Would it be a good idea to

take those by email with, yeah, exactly. We answered them and get the questions absolutely.

but only for the ones that signs up for a trial. Right?

Okay, I'm just kidding.

We will send that. We will answer all the questions and send that to all of you.

Thank you, everyone.

thank you. Have a great day or evening, or wherever you are. whatever time sewn your rent. take care, bye.