 Gwyddiwch. Rydw i'n meddwl gwaith gwagoddol yn meddwl gwaith arall i'r ffaintol gyda'r gweithio am ffaintol sy'n ei ddechrau gyda'r proj pes, ac rydyn ni'n gweithio am y prosiectau sy'n gweithio am ffaintol. Yn amlwg fwy ffaintol o'r Oxford, mae'r byw arwad yn Llarysen i'r newid i'r newid i'r cyffredinol i'r pandemi, a'r pethau cyflwyno yn y llwylliant, byddwch i'r problemau cydnithiadol yn gweithio. The key objectives are to understand the epidemiology of substandard or falsified medical products, we use the term falsified now instead of counterfeiting public health terms, what are their impact, innovative screening technologies for the detection in post-market surveillance, and looking at novel forensic tools that might give us clues as to where falsified medicines have come from, and to use that to influence policy and implementation. And also to build more research groups on this, there are very few globally. Our main funding is from a welcome, the Gates Foundation, and some from the World Health Organization to the UKRI, so these are the main projects we're currently working on. I'll talk a little bit about Forest Fire Envy, and Celine will talk about Epion, and we're starting to discuss having a repeat international conference on medicine quality and public health in 2025. We had one in 2018 here, but the pandemic messed up further plans. So the Forest Fire Project is coordinated by Dr Celine Hawke, who's here, and this is a welcome trust collaborative award to try to gain insight into the origin of falsified antimicrobials. Lots of reader the newspapers about they come from here or here or here, but the actual objective public domain evidence for that is very meager. And then working with sociologists and criminologists in the Department of Sociology here on social network analysis on trade routes that Alberto mentioned earlier today. And we're looking at environmental DNA and stable isotope analysis to try and work out where falsified medicines have come from, building on the pollen analysis work that we did over 10 years ago. We're also working with Ben Cooper and Sean and others in Graham and the AMR groups in Oxford on trying to understand the impact of SF antimicrobials on patient outcome and on resistance. The forest fire team through the wonderful grant from the welcome trust has allowed us to expand to multiple partners all over the world interested in this. But the project I'll allude to today is the vaccine identity evaluation project that for various reasons we didn't talk about much during the pandemic I'll explain why. It's really to understand the epidemiology and detection of substance and falsified vaccines. And this is in collaboration with the Department of Biochemistry Department of Chemistry here, and the Rutherford Appleton lab at Harwell. So substandard vaccines are either due to errors in factories, as in the Baltimore disaster with the COVID vaccine a few years ago, or with temperature excursions of vaccines either freeze forward when they shouldn't be freeze forward, or heated up when they should not be heated up. And there's been lots of work on vaccine via monitors, but they're still not used on all vaccines globally. Falsified vaccines. The first one I'm aware of was from the 1940s, and they're due to by definition to criminal fraud, multiple examples pre pandemic, and then within the pandemic. And Cailen Van Ash, before starting her defil, spent one and a half years trying to monitor the, all the public demand information on SF COVID medical products, especially vaccine. And as you can see, they were very widespread. So in V, the vaccine identity evaluation project that's been funded by two anonymous philanthropic families in WHO, we've been trying to evaluate existing devices to see whether they could use for detecting SF vaccines and supply chains, molded off of which there are two at the JR and two down in the science area, widely used for identifying bacteria, spatially offset Le Mans spectroscopy that you all have seen without realizing it at the end of the security line at Heathrow and Gatwick and I think 150 other airports around the world for looking in a bottle without having to open it. And this was invented by Pavel Matousek, who's at the right there. And we've been trying to see whether this will be able to detect SF vaccines and supply chains, because we couldn't go in a laboratory during the pandemic, the first experiments were in the boot of a car in the Oxford rain as as illustrated here. And we're also working on lateral flow assays that look very promising, and also whole spectrum of lower cost techniques. But how to engage appropriately over this, as I said, we didn't really discuss this very much during the pandemic, because of trust collapse in vaccines, we did not want falsified and some standard vaccines to be used by the more extreme anti-vaxxers as another weapon if you like to beat the vaccine that were essential for us all. But how to get the right balance in terms of discussing these issues, we are now, but things are hopefully, it's now and more appropriate time to discuss this. But also we're very concerned that some of the technologies that we're investigating, if we publish too much about it, criminals could find ways to bypass those. So we've developed a system for outside experts in this field to advise us what to redact, so that we don't make it too easy for criminals to be able to bypass this. But it's a very difficult thing to try and do no harm to do good. You may have heard of the disasters of diethylene and ethylene glycol poisoning in cough and paracetamol syrup over the last few years. The first disaster is the 36, which led to the revamping of the FDA and the USA, but there will be multiple examples over the last year. It's a small grant from the Gates Foundation to try and see whether the techniques we're evaluating in the vaccine project could also be used to form accessible tools for detecting DEG and EG. Thank you. Hand over to Celine. So, afternoon everybody. So I'm going to talk today about Epion, which is the name of a tool that was developed by all these people, the main one being the IT person, the first name, and the WHO with budget from the WHO. So it's a tool to conduct surveys to investigate the quality of medicines in countries with limited resources. So just a little bit of context, the field of medicine quality is relatively new and there is really very scarce data to understand the extent of the problem. And a few examples are the few systematic reviews we published in the last three years, where we found only 106 prevalence surveys, so surveys to assess the extent of the problem between 92 and 2020 for antibiotics. 19 surveys only for cardiovascular medicines and very, very limited numbers of these surveys actually follow a very good quality methodology, including there is no randomization of the pharmacies where to sample. So there is really a need for more and better quality data and there are guidelines, very, very big guidelines with 30 pages from the WHO to conduct these surveys. It's quite complex to conduct. And so recently the unique system that is the WHO Member State mechanism that is a system created in 2012 that convene Member States to discuss and decide and prioritize activities to address the issue of substandard and falsified medicines. So the Member State mechanism advocated for having a tool to help regulators in limited resources countries to conduct these types of surveys to actually know what the problems are and where. And so we conducted this work with the WHO, so funded by the WHO and coordinated by them to develop this tool. And the key words, the key instructions I would say that we had to develop it is user friendliness and intuitivity. So, and also they wanted it to be a generic tool because each survey in different setting will follow different approaches. So, some of you have heard this morning mention of RedCap or Castor, so it's a bit similar tool, but really adapted for regulator in limited resources. It's very hard to explain and it's an online tool. It's very hard to explain an online tool on slides. So I have some videos, but just as a context, one important thing as I just said is that each survey will be conducted a bit differently in different contexts. And I'm taking an example as an example here, the configuration for the Tanzania regulator, where we piloted the tool in Tanzania. But for every survey we will have a coordinator, so at the top of the picture here. In Tanzania there were regional survey managers who are supervising collectors, the collectors being the ones collecting the medicines in the pharmacies and health facilities. And there was lab coordinators or the laboratory where the tests of the quality of the medicines were done that who supervised laboratory technicians. But what does this survey coordinator does in APN? So APN is really helping the coordinator with limited knowledge in these types of surveys to set up a methodology for it. It helps him or her to randomize the outlets where the samples medicine should be collected by uploading a predefined list of pharmacies and doing randomization. Different types of randomizations are possible, simple, stratified, etc. And that's only pressing one button, which is really interesting in that case. Also the coordinator will assign activities to the different actors of the surveys, a little bit as in RedCap for those who know. Once the list of outlets has been uploaded to APN system, APN will create a map of the outlets that were selected for a visit by the collectors. That's very useful to then assign to specific regional survey managers, the regional survey managers being the ones supervising directly the collectors. To assign these outlets to them so that the collectors can then also be assigned the outlets. So we will have a look at the video that's a bit more easy to understand on the role of some of the activities regional survey managers do. So hopefully it's going to work. It's a video that was made for the training of the team, the Tanzanian regulators for the pilots. Once you're logged in to the APN tool, your first task is to create a collector's account. Click on the Tasks tab and add a collector. Here you will need to add their name and their email address. The collectors will receive an email with a link to download and install the app on your smartphone. Don't worry if you make a mistake. You can easily delete the collector's account by clicking on the trashcan icon. If for some reason the collector did not receive your email or accidentally deleted it, you can resend the link to them by clicking on the envelope icon. This will send the link to that email address again. Your next task is to create an assignment for the sample collectors. Click on the Tasks and choose to assign outlets and lists of outlets from the drop-down menu. Choose a collector on top of the page. Here I have an Italian John, so I'm going to choose John and assign a task to him. To assign an outlet, simply tick the box next to the name of the outlet you would like to assign. That's just to have a brief overview. Okay, let's have a look now at how the collectors can use Epion. So, when they collect the medicines in the pharmacies, they have to fill in some information. In that survey in Tanzania, the WHO had printed a form on a bag where the collectors would actually then fill in information in the bag, the medicines, and it's then filled. But they also have to enter this information in the database, in that case in Epion. So, that's what the interface looks like. It's a smartphone interface. It's not an app, but it's a website that looks like an app on the phone. We will have a video as well. The good thing about it is that they can do the data entry in Epion offline and then save later online when they have a stable Wi-Fi connection or internet connection. And it also uses optical character recognition to show us the key on having a tool that will reduce the work that the collectors are doing. So, instead of having to re-enter this entirely on Epion, a tool the OCR will read directly the information and enter it in the database. But let's have a look at the video. To start your assignment, open the Epion app on your smartphone. Before you are assigned samples to collect, this home screen will appear blank. Once your regional survey manager assigns your name to a task, your assignments will appear here. Assignments, which have not yet been completed, will appear on a clear background. Finished assignments will appear with a green hand icon next to the outlet name. A red hand icon indicates that you have completed an assignment, but it hasn't been handed over yet. To start your assignment, click on the outlet's name to see the outlet's details. If you don't have Wi-Fi or data coverage, you can save the information offline. When you do this and return to the home screen, the assignment will now appear in a red frame and with a disk icon next to it. This indicates that the information you have entered on this assignment was only saved offline and will still need to be saved online. You can continue with your assignment by clicking on the glasses icon which activates the optical character recognition system. Now Epion will ask you to take a photograph of the bag. When taking a photograph of the bag, please follow the Good Picture Guide which you can find at the end of this module. After you have taken a photograph of the bag, adjust the frame of the picture, ensuring that the white sticker and the sides of the bag are within the frame and click Submit. Double check the information of the outlet, enter the collection date and specify your approach. Record the temperature and the humidity in the area. If the information on the bag is written clearly, the OCR system will recognize it and automatically fill out the fields in Epion. Check the information because the optical character recognition is not 100% accurate, especially for those who write with very bad writing like me. That is basically the assignment mentioned about the probably understood that the names of the pharmacies there are Tanzanian pharmacies in here. They directly have on their phone where they have to collect. There is information if available, there is a GPS location. You can even click on the map and just get the directions from the map directly so that's very useful. On the bag there is a barcode, a unique barcode for each sample. Once the medicine has been created in Epion, you scan the barcode and it's saved with this unique ID within Epion. At each step of the survey, the users, the actors will scan the barcode so that we can track where the sample is and with who and when. Since when basically. At every step. Let's now have a look at the last part of the survey which is the laboratory analysis of the samples. Once the samples are shipped to the lab, there is a coordinator and the lab coordinator will assign samples to specific technicians in the same way the regional survey managers assign the outlets, the pharmacies to the collectors using Epion again. Then there is a specific interface online for entering the laboratory test results. Also one nice feature of Epion, it contains dashboards. Dashboards for monitoring the survey such as this one. We haven't worked too much on the design of the dashboard yet, apologies, but we will. So this dashboard, for example, shows the number of samples that have been collected out of the number of samples expected to be collected in you can filter by region. If you're doing a national wise survey, you can have a look whether there is specific problem with the survey in specific region for a specific collector, et cetera. There is also dashboards for monitoring the results of the lab test, for example. Importantly, Epion saves data in a whole same database that is secured and relational. There is many other features that I haven't shown. We have finished these pilots and we are working with the WHO to make Epion more generic because it's been tested for Tanzania configuration but not for other configurations. So this is led by Edo now, Katie here is leading that so we are discussing contracts. Thank you.