And
Monica Harry: okay, Two minutes after we we'll just start slowly. So hello, welcome, everybody. Thanks for joining um. This is our drug content uh Content analysis project
Monica Harry: next slide, and well, you can see It's, honey, and Julie are going to be co-chairing the group and I'm: basically the support light on from the internal and as nomad international side.
Monica Harry: And this is our agenda for today. So we've had meetings uh the three of us, Julie Hanny and I to talk about. Well, mainly Julie and Hanny planning the process, and how we're going to go about this
Monica Harry: um,
Monica Harry: so you can go back, and I can see where your head is, and I thought i'd better go there.
Monica Harry: So
Monica Harry: what we're going to do today really is, Talk about the um. The work process tell you what's been done so far. Um! There are a couple of specific topics for discussion. Um, The anti-infect is explain Why, that's the first thing we're going to look at, et cetera
Monica Harry: um, and then talk about the next meeting and timing. It's one of the things we want to talk about the next meeting. So I guess Yeah, the next slide we can actually probably skip it because it's.
Monica Harry: Uh, did I? I My footnotes on? Uh, okay,
Monica Harry: I guess you can see the So this came about because, as part of the drug extension user support group, there were conversations around Uh perceived missing content in the international release with regard to drugs. So we've talked about. What could we do if there's so many crs requests trickling, and one by one was not going to really be very efficient.
Monica Harry: So this discussion today and this group, really the job is to look at the um
Monica Harry: uh gaps in content identify those within. A. You know, the initiative being to improve the content in the medicinal product hierarchy,
Monica Harry: and really, importantly create an efficient process to identify and offer that content.
Monica Harry: Obviously all the usual um
Monica Harry: approvals uh, you know, guidance, et cetera um. Authoritative reference sources. Is this: a real drug doesn't exist, and all that has to be in place. Um, I think the next slide is probably moving over to you, Julie.
Julie: I think he does. I can't go on mute because i'm recording. I just um echo.
Julie: Monica is welcome. Thank you. It's just great to see so many of you here.
Julie: Um,
Julie: I just like to do a very quick update on what we've done when I say so far, I mean um, since we all met, either in person or online um for the Lisbon business meetings, we had this sort of the first of of this this group.
Julie: Um! And at that point um. Hannah offered to to chair this group uh with Monica and myself for myself. Um! And um.
Julie: Her boss uh volunteered some of her time to work on this, which was just brilliant, and we could not have got to this point. Uh without that work that honey has put in, and what we've tried to do is work out a methodology for how we can work together
Julie: to assess new content. Um to fill our gaps, to to meet that needs that we're we're hearing from you, and the wider de usg community that you represent. So, honey, Monica and I have been meeting weekly
Julie: uh to try and work this through, and and what we did was, you know you can talk about this in the abstract forever.
Julie: We needed to make this concrete. So we selected a therapeutic area, and and we selected anti-infectives because it's something that we all have to deal with.
Julie: Um, It reflects quite a global um,
Julie: a global need. And so you know, our
Julie: uh, our global responsibilities uh to the community. Um! We all have to deal with infections, but we do have different infections depending on where we're based. Um what our geography and meteorology is like, and so forth. Um, and and so it's sort of It was a good area to start with.
Julie: It's also an area where there's been quite a bit of change.
Julie: Um, particularly obviously in treatment of viral disease and Hiv, but not so much change that we'd be overwhelmed. I mean, if we picked some of the monoclonal antibodies. Um,
Julie: we'd all be, I think, looking at lots and lots of change. So this was. This is quite a good area to start work on,
Julie: and uh what we decided to do was to get an initial set of concepts in this therapeutic area. Um, that we think uh,
Julie: in a sense missing and and assess them, and you have to start somewhere. As I said, Um, you Andre had, volunteered Hannay. So we've started with the Norwegian data,
Julie: and um. Hannah has developed a process to look at the the data that they have in their national extension and compare it to the international content, and see where the gaps are, and in just one moment she's. She's going to talk about that because
Julie: um! That might be a process that others of you can follow or adapt, or or might give you ideas about what you would like to do with your own content.
Julie: But once we've got honey's, initial set of things that we're in a sense the gap.
Julie: Um. I did an initial assessment of them. Um trying to see how many of those actually did Full, for example within the the standard editorial guidance. We have now um, for example,
Julie: um in Norway for, or an antibiotics at the moment they're using the manufactured this form, whereas in the International we have a policy that we will use the administrative dose for. So I could sort of identify um sets of things which
Julie: we might need to discuss in the future. But we which in a sense, we're clearly not so much gaps as differences. So then, having
Julie: having
Julie: in a sense filtered those out. We have a first set that we'd like to talk with you about as a as a process of assessment.
Julie: But i'd like to go back to this part about Hannah's process. Um! So that, as I say, you can either copy it or get ideas from it, or just think Oh, Well, that was interesting. At least we know how we've got where we've got.
Jo Goulding: So you guys taking away, I guess, built it down and reuse whatever pulp
Jo Goulding: that turned into something else. I don't know. And it is such a complicated
Okay,
Hanne F. Johansen : Um, I just don't jotted down very fast how we work to get the
Hanne F. Johansen : our list. Basically So um, if you switch to the next slide, Julie.
Hanne F. Johansen : So um.
Hanne F. Johansen : One of the things in our model is that we rely on the international model with some modifications for the Norwegian content. So we don't use the real package, drug and everything else.
Hanne F. Johansen : So most of the things that we've made are at the clinical drug level
Hanne F. Johansen : um, or a Mpx or and piece.
Hanne F. Johansen : Ah, largely, and we have made them based on a process uh in collaboration with the Norwegian Medicines Agency, mapping their structural data or their building blocks like pharmaceutical dos for us, and as substances used in clinical drugs one
Hanne F. Johansen : and strengths and everything, and then, based on that done queries to what exists as a clinical drug system, that that combination of building blocks, and what is missing,
Hanne F. Johansen : and for what was missing. We've generated Norwegian clinical drugs to bridge the gap for the need we have in in that project.
Hanne F. Johansen : Um! So what we did for this to to create that list of anti-infective. This time um was that we uh produce a query based list for the category of anti-effectives.
Hanne F. Johansen : We did a a query very simple. One child of medicinal products with ah has ingredient, or has active ingredient or child thereof that is an anti-infective agent
Hanne F. Johansen : that's it and we generated a list and then constrained it to
Hanne F. Johansen : only a specific ref set that we use to find actual products to the identifier out the
Hanne F. Johansen : produced and manufactured and distributed drug in Noma's registry.
Hanne F. Johansen : So everything that's more administrative is peeled away, so we only have those that are connected to manufactured and distributed clinical drugs that are um
Hanne F. Johansen : distribution in our way.
Hanne F. Johansen : And then we further peel down that list. When Julie went through to see what matches Ah, international standard, and what is more,
Hanne F. Johansen : um for our own use, more granular um
Hanne F. Johansen : pharmaceutical, those forms, or, as she said, uh manufactured instead of administerable those form for pharmacy. You know we all um anti.
Hanne F. Johansen : Ah, biotics
Hanne F. Johansen : ah! And hydrate form and everything else that we have, like the data, sets a hydrate or try higher day. But according to international model, we won't use. Step forward.
Hanne F. Johansen : So we further kind of constrained that list until we got what we suggest today.
Hanne F. Johansen : And then i'm working on still working on, adding in the references that I can find in Noma for the actual products that are connected to that clinical drug.
Hanne F. Johansen : And then, yeah, the next to the slide, please.
Hanne F. Johansen : This is kind of how it looks right now. We're happy to have some some feedback if you want it changed, but you're going to get the link to
Hanne F. Johansen : the actual document, and you can download and fill it out
Hanne F. Johansen : for yourselves. But the main idea is that
Hanne F. Johansen : we've filled out the blue part with what we have in the Norwegian module um to show you the Fsm. If you want to. You can also pull off the
Hanne F. Johansen : the Ids and check them in the Norwegian browser or the Norwegian daily build. If you want to see the modeling
Hanne F. Johansen : that's possible,
Hanne F. Johansen : and also giving you the brand name and the supplier that is registered in Omaha today, and a link to the Sfc. If I can find it.
Hanne F. Johansen : And our thinking was that you guys would fill in the green part,
Hanne F. Johansen : and within there there is a decision. So you can choose from four. We we might um write them out a bit more. But there are categories. Ah, four of them. I think
Hanne F. Johansen : so. One is. Yes, we have this clinical drug in our national extension as well,
Hanne F. Johansen : or in our medicinal products, module or whatever, and we support to include this clinical drug as specified by the
Hanne F. Johansen : Uh fsm. In the International,
Hanne F. Johansen : and then we have a similar clipal drug in the national extension we support inclusion. But we need further discussion
Hanne F. Johansen : to figure out, if we need both our suggestion and your
Hanne F. Johansen : similar, but not quite, or both,
Hanne F. Johansen : and and all of those
Hanne F. Johansen : explanations will be in the spreadsheet itself in a different table. So you can go back and read to kind of remind yourself which category you want to choose, and then a a point where you can
Hanne F. Johansen : um describe Why, one would like to include it. If you have an Smpc or something else, or even the concept, Id and some of your local clinical drug, should such a thing exist, so kind of just paste that in there,
Hanne F. Johansen : so that we in the end can go back and see. Okay, you guys, or more than two countries, have supported, or more than three, or however many want to participate,
Hanne F. Johansen : support, inclusion, and why? And if we can find more for this than just ours
Hanne F. Johansen : for Smbc or other sources to an actual manufacture product that is, in circulation
Hanne F. Johansen : in Europe or other, where everywhere today, so that we can see that. Yes, this is not just abstract. This is an actual clinical drug.
Hanne F. Johansen : Um the product matching the clinical drum description somewhere.
Hanne F. Johansen : That was our thought, and how we work till now. And i'm thinking, Julie, we're going to add a sheet for
Hanne F. Johansen : maybe more details of other national extension
Julie: about offering other cities.
Julie: So so this is the the sort of the process that that we thought about. Um apologies. I've used the European um abbreviation for, in a sense, a formal regulatory document, or something that formally supports the fact that this is a a real thing that we then abstract to being a clinical drug.
Julie: Um, So so this is, in a sense what we've done, and you know, we said a member. In this case it was Norway, and we said, based on the therapeutic area. And as I said, we started um
Julie: with anti-infectives, and we've as Honey has said, got this um for the draft of a spreadsheet to review. I just thought I throw in some figures when we started um with anti infective. The list was about seven hundred, and I went. My goodness!
Julie: Actually, when we've done the initial analysis, it's gone down to about one hundred and forty.
Julie: So i'm just so that you know this sort of a volume that that
Julie: we're thinking of,
Julie: and um at the moment, just as Honey said, we've, we've got a decision around, in a sense, A B, C or d um, There might be something I I haven't particularly thought of. But you know, basically. Yeah, we've got it. We'd like to see it as an international. Cd:
Julie: Um, We haven't got it,
Julie: but we fully support it's inclusion. And and what I've put there is for uh, particularly in antibiotics. Um it. One of the things I've noticed is that um in Hannah's spreadsheet they use a fluxes in a lot
Julie: uh Is it a flux in, or I know a flock cylind something like that? Just not something in my culture here in the in the Uk. We use It's not when in our formulary, but I can fully see that at a global level we need to be able to describe. You know that
Julie: the oral preparations of this and the intravenous preparation for this, because it's a commonly used antibiotic in another country. So, although I don't
Julie: have it.
Julie: Personally, I i'd fully support it as long as it's perfectly referenced. Um!
Julie: I am very conscious that there will be some slight differences.
Julie: One of those differences is around. Um! How our data is actually presented to us. Um,
Julie: and thank you that that's fine, and and we we can see that you you can't change your name and detail. Thank you for joining Um.
Julie: There's a product in here whose brand name I completely recognize.
Julie: Um, but the way it's described in the Norwegian data like um data is different from the way it's described in my local data.
Julie: And i'm thinking, Hmm. Are these really the same thing, or are they different? And you know we want to be careful.
Julie: And so um, you know that's where we want to to note differences and discuss,
Julie: and then there will be some things, I guess, where it's. We will look and say, do you know what That's
Julie: I don't think that should be included? Um,
Julie: I was looking at some dental solutions, and i'm on within our used cases. Are they things that we need for, for example, to support global interoperability? Or are there things that we'd say
Julie: national extension? Only A. And you know,
Julie: if there is a thing, if you find things like that, we really need to know. And um please give your reasons, and as you're going through, I hope you will find i'm sure you will find um Cds that
Julie: we haven't got in this spreadsheet, and we need to put that process in um to to get those in there, as Honey was saying. Maybe we need another and um
Julie: uh sheet within the spreadsheet,
Julie: and if all that works, and we then will have a set of Co. Uh contents that we would
Julie: submit for consideration.
Julie: I'm hoping that if we've got lots and lots of evidence, that consideration will be almost a rubber stamping process. But you know that's something that Monica and her team will have to decide,
Julie: and today at least um, I suggest we don't go into the details of whose identifiers and how we have talked about that there are all sorts of possibilities. But at the moment we just want to get in a sense, the data side going Um, And and then also it will have a sense of volume,
Julie: you know, if every one of the hundred and forty that we've got on the spreadsheet is accepted by the majority of the folk on this call, and another
Julie: fifty are added. That's
Julie: that's a different, you know. That's one volume. Um, if it comes back, and everybody says you know what. We only accept twenty of these. That's a totally different volume, and probably a total different mechanisms. So that's something we'll discuss in the future.
Julie: But hopefully, if this works and or it gets modified to work better, we can then select another therapeutic area together and and go forward.
Julie: So I will pause there for a minute to take um
Julie: comments, criticisms, anything else that you would you would like to share? Is it what you expected? Is it wildly different from what you expected. Anything like that,
Jerry, Do you want to start?
Jerry O'Sullivan IPU: Yeah, I'm actually
Jerry O'Sullivan IPU: fighting cars by what i'm hearing
Jerry O'Sullivan IPU: um. As I said, we way way back. There was far too much contact missing from the international Addition, and I suspect that has resulted in a lot of countries
Jerry O'Sullivan IPU: uh putting their clinical drugs in in in their national extensions, because they physically simply aren't in the internationalization. Um, i'm. Just curious. Do you have the feel for roughly
Jerry O'Sullivan IPU: like the big criticism I think I would have in in terms of the current regime, is it's? It's very cumbersome, and take it there's a lot of uh it's very time consuming, and I understand why.
Jerry O'Sullivan IPU: And there's a lot of cross jacket that needs to be done. And but with this like, because you have an established um
Jerry O'Sullivan IPU: set of of of records within the the the Norwegian regime. Um, do you have any fail? For
Jerry O'Sullivan IPU: how quickly, how that will speed up the the the submission of um records for the international release.
Monica Harry: Yeah, that's the next stage is um.
Monica Harry: And if you're right, Jenny, this is gonna work very well, because this means that people will have the drugs in their extension. If if what you're saying is correct, so then we can look at doing batch or other,
Monica Harry: I said, I love you already,
Monica Harry: but a lot of that does depend on the quality, if I may say so, because if we have to make a lot of changes because they've not been modeled properly or at all. There's nothing we can do about that. That's just part of the process. They have to be um modeled correctly to fit in with our model, so
Monica Harry: we'll find out. But I think the fact that we can possibly look at doing things in batch. Your bulk will make a huge difference,
Julie: and you should be able to tell from the Fsn. What this is, and if that's not the case, please note it in the spreadsheet. Say, i'm sorry this is ambiguous. Um! We need more detail. Um, but we are hoping that we have got
Julie: enough from the Fsn. Although obviously, when we put it in, we've got to fully fill in all the Mrc. And attributes Uh yeah,
Guillermo Reynoso: um,
Guillermo Reynoso: yes, thank you. I hate to always be the auger here. Um! This was not what I was expecting. Um, but uh, I I obviously don't have a
Guillermo Reynoso: a a problem with it intrinsically. But if this uh
Guillermo Reynoso: uh, this is a priority for us, it's like, uh, we try to do to to understand what animals we will be dealing with first, and you say, Well, uh, there are some elephants in the room, and perhaps we uh it depends on, I I think, uh,
Guillermo Reynoso: what kind of integration. And what kind of use cases you want to support in your national extension, or in your national
Guillermo Reynoso: direct database uh in general, one of the primary purposes is to be able to integrate with the rest of the data you
Guillermo Reynoso: you are recording uh in in other
Guillermo Reynoso: um in other, and to have it to be able to detect, uh, perhaps a problem with the adverse reactions or prescriptions, or whatever use case you are, you are trying to support. And uh
Guillermo Reynoso: in uh, in general, you are starting from
Guillermo Reynoso: uh, instead of real products in every market that really exist there.
Guillermo Reynoso: So and you have to try to connect to them with the upper level classes, and hopefully you could connect them with Cds and the but that is usually an evolutionary approach, because it depends on you, having the correct modeling
Guillermo Reynoso: and the the appropriate mappings in place, and all the standardization that is required by to to be able to
Guillermo Reynoso: to comply with the international addition. Um
Guillermo Reynoso: uh standards for for modeling that. So? Uh, at the very beginning. And I think uh, this is something that is affecting
Guillermo Reynoso: those countries that have a Dmd like uh
Guillermo Reynoso: Oh,
Guillermo Reynoso: um clinical rock databases models um At the very beginning you want to integrate uh to the Np. Contains, or Mp. Only Mp. Only form, and so on. So you need to at least be compatible with that. And you need at least to be sure that uh
Guillermo Reynoso: um. If you have a substance, that,
Guillermo Reynoso: or an ingredient that is not in the international release, then uh us, we should have that in the international release as soon as possible, because, uh, otherwise we have the risk of uh creating different uh
Guillermo Reynoso: substances different uh concepts for the same substance uh everywhere. So they cover us.
Guillermo Reynoso: Uh in the for international dry extensions. The first problem is usually
Guillermo Reynoso: um
Guillermo Reynoso: Whether the substances are are probably reflected. Are there substances in in Norway that are ingredients on the for valid Norway
Guillermo Reynoso: product that are in the market without consideration to whether they are valid, or I mean, if they are in the market in certain way you need to represent it. Yes, if someone is going to be prescribing it, you cannot say. Well, I am not sure I will support it
Guillermo Reynoso: uh inclusion of the Cd somewhere. Yes, you have to have a solution for that. And if uh, that ingredient, or that substance is not an international release. We need to know it
Guillermo Reynoso: as soon as possible, because otherwise other countries that are publishing full extensions in the in the short term like.
Julie: But of course we we can't you. You forget what you've got. We have to work upwards, and we can't have a clinical drug unless the proper substances exist. So this process will require the addition of new substances.
Guillermo Reynoso: But the problem is that we need at first to be able to at least know whether they, I mean, there are. There are several areas that are already jurisdiction of the international release, like the upper level classes. Yes, Mps, and the only is
Guillermo Reynoso: the only forms, and even for the forms, the Mp. Only forms are only at the intended site
Guillermo Reynoso: uh level. They are not detailed. But,
Guillermo Reynoso: uh so,
Guillermo Reynoso: if we, I mean, if we take all the folks in the market, and we start modeling the the accents and then classifying them against
Guillermo Reynoso: it's now met international release. Then we will find that there are high level classes available, clinical, direct that are not there. And then you start, fall. You start finding the clinical drug that are missing by classifying against the international release.
Guillermo Reynoso: And if you classify, or if you get the information from several extensions
Guillermo Reynoso: as can contribute, and you classify them together, and you find the equivalent. So you find
Guillermo Reynoso: that they are not finding any new parent in the international release. I think it is the another way of doing the such a scale. That will be easier rather than going, you know. Uh clinical ripe for clinical rock.
Julie: So we actually did that for Norway for Mps and Mps.
Julie: Um.
Julie: We We did that process, and we did have
Julie: a small number
Julie: of Mps and Mps that would need to be added. Um! From what I remember it, you know it's It's down at twenty for for both. Um. So in a sense, we did
Julie: try and do that that process as well, and it gave us a much smaller uh set of things. But of course they would be added as the clinical drugs um
Guillermo Reynoso: went in um what we sorry That's sorry, Julie. That's it. Asia. If you have twenty Mp. Contains, or Mp. Only that uh are in there, nor regeneration, or in the Norwegian.
Guillermo Reynoso: Uh. My point is, can you submit them to the call? Can we also meet those into the core, and they'll be able to at least discuss
Guillermo Reynoso: or have a consensus on all of them. So you would like to do this process, but not at Cd. You'd like to do it at Mpf. Only, and Mp. Only
Guillermo Reynoso: at the very beginning, because otherwise, if uh the point is to being able to classify under a Cd, you have to have it fully modeled. Yes, and you are even talking about just looking at the Fsm. But if you have it fully modeled uh it, it is a lot of work, and it uh,
Guillermo Reynoso: and the there are many other uh requirements, and it will take a significant time, however, to bind, for example, your Bmp.
Guillermo Reynoso: Uh to the appropriate Mp. Only it's a it's a only a low hanging fruit, and you can integrate most of your existing model.
Guillermo Reynoso: Um! We, for at least the upper levels and be able to support the least a series of use cases. But it will be discouraging if, uh, you have to create to those concepts in your local extension, and then find out that someone else has the same problem. And then the third person that had that problem submitted those to the international release, and then they were created. Theoretically, no country should be creating Mp. On this.
Guillermo Reynoso: If, uh, there are valid
Guillermo Reynoso: uh, if those are valid uh products in the market Uh, those should be created in the international release. So in terms of coverage,
Guillermo Reynoso: I think one of the highest priorities is to have
classes,
Guillermo Reynoso: so the the we can do that much for the release.
Julie: So so thank you. Um, I I hear what you say. I I've taken full notes of that we would, of course, still need the um
Julie: the supporting documentation, and it is I'm I would be. I. I do personally worry about having Mps and Mps, which have no um understanding of of what
Julie: came from them. But I would really like to hear from others, please. As to to firstly, what you think of the process. Secondly, what you think of Gamma's comments. Um, because we can certainly, if if that's the way we want to go, we We already have
Julie: um the data from Norway. Um for just Mps and Mps, and it's a very small. It's a much, much smaller amount. Um! So i'd really like to hear from others of you, please. Uh what you think about it.
Julie: I can see Jerry's hand. I know you. You've spoken to us already, Terry. But um, since nobody else is washing in, and I really do you know this is this is for you guys. But um, please go ahead, Jerry.
Jerry O'Sullivan IPU: Yeah, I I hear what I was saying. Um,
Jerry O'Sullivan IPU: but my! I but I also agree with you. You're saying that this is a
Jerry O'Sullivan IPU: a but kind of a bottom up, approach, and like if, say for our in the sake of what the
Jerry O'Sullivan IPU: the B you're dealing with, say is one hundred and seventy records
Jerry O'Sullivan IPU: from then from the Norway from the Norwegian
Jerry O'Sullivan IPU: a system um like if they were all submitted. Um, i'm quite sure that you'd find an exact match for
Jerry O'Sullivan IPU: for most of them given the existing snow mess structure. Now there may be a small minority Where? Because the the Mp. Structure is missing and you won't get a match, and i'm just wondering
Jerry O'Sullivan IPU: a if that might be a better way to approach this. And then once you add that that Mp. Structure um, Then the the remaining records should match.
Julie: Thank you, Jerry. Emma:
emma melhuish: Yeah, hi, um! I I hear what i'm saying about the the idea that it's the Mp.
emma melhuish: Or the Mp. Containing that we need, and the Uk is actually moving for that being that point of linkage into the International Day to now where we're going to actually for our clinical drug. Equivalent concepts are actually going to have extension. Ids
emma melhuish: um. That makes sense in a a lot of ways. That is the the priority to link those. The problem that we've had in the Uk is
emma melhuish: where we have offered to to populate um The equivalent
emma melhuish: concept for the Uk to support things like clinical trial or overseas. And we've had problems getting good data unless we've actually got a license product to back it up, and that
emma melhuish: It's not necessarily a blocker for the Mps. For the Mps. I think I would not want to create an Mpf. Without knowing that there was a clinical drug to support it.
emma melhuish: Um, you kind of run into problems where people will say, Oh, this is a parental product, and then, when you finally get it's not just parental. It's parental and all, or whatever. And you get into that kind of mess. So Mp: only
emma melhuish: Yeah, um. But I think you you might struggle with your day to get good quality day to saying exactly what it is. Um! The Mps. Without a clinical drug
emma melhuish: I would be cautious.
emma melhuish: Um! I I complete check on board what what you must say, because I think this could be a lot of work with people going through and identifying clinical drugs. But I would hope that that's an initial set up cost, and once
emma melhuish: once the the dictionaries are more aligned because of the way big farm works. Now,
emma melhuish: when something is launched in one country it's quite often launched in multiple countries. So we shouldn't be having to do this volume of work
emma melhuish: continuously. That's my hope some days. Thank you.
Julie: Thank you, Emma. That's that's very helpful.
Julie: Others of you keys there's lots and lots for you on this call.
Jing Jing (IHiS): Hello, uh, Jane! Hi, Hi: Yeah. So i'm just um
Jing Jing (IHiS): uh looking at the um process. Let's say, if let's say, um, Singapore, we have the Cd in our National Um dictionary, and we do have our local Uh Smpc equivalent. Um, actually,
Jing Jing (IHiS): would you consider like, Is there a minimum number of um countries with this uh meeting this criteria before you add it into the International
Jing Jing (IHiS): as a clinkle drop or um, Let's say with that, say we go with um your most um
Jing Jing (IHiS): direction, which is to just at the at the Vm. Key level uh which is the Mpm. Pf. Um. That would actually reduce a lot, I mean, uh reduce the burden of um
Jing Jing (IHiS): having this uh very precise uh modeling uh involved.
Julie: So how many? I think the question is, how many countries would we need? And I think. Um, we'd very much need to to see whether
Julie: what we would do about Mps. Because um
Julie: we really do need to make sure that we're we're supporting it, Monica. I think the standard is three countries. Is that right?
Monica Harry: Yes, Julie, that's right.
Monica Harry: Yeah.
Julie: So once three countries said, Yes, um. And we could, you know, have matching data for three countries? That would be our Yeah. Let's go.
Jing Jing (IHiS): Okay, Thanks. Um,
Jing Jing (IHiS): it. Some
Jing Jing (IHiS): Um. Hi.
Jing Jing (IHiS): Yeah, um. So for no way. Um, you did mention that, uh, for on your side you're trying to model or find a equivalent for manufactured product. But the International, currently, the clinical drugs are or in the administrable phone.
Jing Jing (IHiS): Um! That is where you are having. Problem, Uh, is that one of the key reason for this uh initiative?
Julie: No, that was sorry. That was just a very small proportion of where Norway's done. One thing that's different from the um
Julie: what's in the International? And, in fact, we've taken all of those out. They're not in this this spreadsheet of one hundred and forty items. What's in the spreadsheet of one hundred and forty items are Cds: that would fully correspond to the International editorial guidance.
Jing Jing (IHiS): Right? Okay,
Hmm.
Ian Spiers: I Hi, Julie, it's in. I just wanted to sort of recap What cameras
Ian Spiers: consideration is,
Ian Spiers: I think, in truth, I should go further down the tree. There's more concepts to add
Ian Spiers: underneath
Ian Spiers: the form basis. So when you go into Cd, so I understand that if there's a certain resource and time, then you could populate.
Ian Spiers: The Mp. Only is quick. I'm not probably quicker to model
Ian Spiers: the only caveat to that is, you would always still have to look at the regulatory document to all of that. And then, when you come back to all of the Cd. You'd have to go and check that regulatory
Ian Spiers: document again. So there is a duplication in terms of checking
Ian Spiers: when authoring,
Ian Spiers: but
Ian Spiers: I can see that it would lead to, maybe a lot more
Ian Spiers: content being added at that higher level
Ian Spiers: in a quick process.
Ian Spiers: But in the long run it might take longer,
Julie: and and to the point about substances. When you enter substances for Mp.
Julie: You are entering at um the active ingredient substance. You're not at entering at the precise, active, ingredient substance. So in your national extension, when you needed to end. If you needed to enter a precise, active, ingredient substance that was different, you would. Still, we would still have to go through some
Julie: Crs request process to to do that. So there would be some additional duplication of effort there as Well,
Ian Spiers: yeah, um, I think as well that we need to consider the substances on always just for drugs. They could be for
Ian Spiers: a requirement for allergies and stuff. Um. So you know, substances, if people feel those things messing in the substance hierarchy, they can submit crs just for substances, anyway, whether the drugs or not
Guillermo Reynoso: sorry, Julie. I disconnected before
Guillermo Reynoso: um. I I think that we
Guillermo Reynoso: we are starting with a local drug railways. Yes, uh, and in most cases that database, that national database that is, in whatever format is. Uh
Guillermo Reynoso: uh, it's a in some way already incorporating the regulatory, the local regulatory information. Yes, so you have the information from the regulator for your country. Yes, so what you do.
Guillermo Reynoso: You have a lot of uh things that could be eventually a clinical drug, but they have completely different model. Yes, and so you and you say I need to be able to bind. You know these clinic. They said this drug in my local direct dictionary to some is number concept
Guillermo Reynoso: to test whether, for example, if the patient is a logic or it's, the patient is that's a and so on, but I have years of it for to transform my local database into the full uh the extension model, and the it may be that you will not be adopting the entire
Guillermo Reynoso: yeah national extension model. So what are the first things you you do? You take your
Guillermo Reynoso: your real products and eventually try to, uh, ensure that your uh substances are mapped or are using it's it concepts. And so you have your substances. It is a very likely that your substances,
Guillermo Reynoso: or your ingredients at the real
Guillermo Reynoso: road level are more precise than the upper level classes. But that's a that's fine. Uh you have them at.
Guillermo Reynoso: Then you look at the those forms, for example, and your those forms have a mismatches because of different issues. Yes, but to to be able to classify under an Mp. Only form or an Mp. Four, you only need to at least have a mapping at the
Guillermo Reynoso: at the level that they, those Mp. Only forms are created, and most of them are just using intended site. So whether it is a capsule or it, or a tablet, Really, what you have is that all of those from they are. That's Np-f:
Guillermo Reynoso: Well, you have Mpf, and you have a Mp. Only if you have a both of them at this time You also have a Mp. On list, and you have Mp.
Guillermo Reynoso: For Mps that have a multiple ingredients uh that. I'm not sure why they are there, but they are, they are there, we. So the point is, if you take all the clinical drugs that exist in the core. Yes, uh, all of them have uh in the axioms. They have medicinal products,
Guillermo Reynoso: and when you classify all of them uh having the perform except the five or six, all of them have uh their corresponding Mpp only whatever upper level class. Yes, they are complete. They have all, all of them. They have Mp. They have Mp. Form, Mp. Only,
Guillermo Reynoso: and the only forms they have all those four classes.
Guillermo Reynoso: When you have mapped your your substances or your local drugs,
Guillermo Reynoso: real drugs, and you were able to attach a substance and a form to those from that is at least
Guillermo Reynoso: uh the intended side level. Then you can create the axioms and the even though those base actions. We've got a bridge model, and you can classify that against the summit. And you'll find that some of them will find the appropriate parents will find
Guillermo Reynoso: Yeah, appropriate
Guillermo Reynoso: Mp. Only Semp: Only forums, and so on, and some others will find nothing. And so in certain way, those will, when those who are when you divide them after classification after classification in the interform they continue to have medicinal products in the
Guillermo Reynoso: uh as the parent. If so, you know that the clothes are not. They are those are not. They are perhaps because they substance exist, but the they they were not. They were not created in the core, or perhaps they substance that's not exceeding It's not an international um needs to be submitted. And then
Guillermo Reynoso: what you said before I think is well. Are we allowing that substance or not? And the are we accepting that that substance or not? And you say, Well, perhaps this substance is only used in Asia, or it's only using South America, and we are not accepting it. Well, my, it's not. I mean they should here for the country it.
Guillermo Reynoso: If the substance is accepted. We would like to have a uh international. Id
Guillermo Reynoso: to use it if the substance is not accepted. That's not a problem yet, because you you know that your substance is not accepted, then you can use it locally. Yes, and you can create an idea locally. The the problem, Really, if when you create a local Id, And then,
Guillermo Reynoso: you know, a few months later, or one year later uh the substance is actually accepted
Guillermo Reynoso: just because you Haven't submitted it for promotion. You, Haven't discussed that, or because it was, there was a change in the material policy, and then you have to change your locally the venture and retar your steps. And so the problem is, the stability of the Id is not really
Guillermo Reynoso: uh whether they substances, if if they are or or not. But in in general we know that if we create a local Mp. Only, or Mp. Only forms, or whatever uh, those are global concepts, and they should be in the course so essentially
Guillermo Reynoso: we can. We will need a process for, uh, the making our real product classify under the appropriate clinical tracks. Uh and uh, we have a
Guillermo Reynoso: experience with two D for two or three different patterns for the those extensions, and all of them have different challenges, some problems and advantages and disadvantages. You have a pure
Guillermo Reynoso: uh national extension models, extensions like uh the Argentinian one, where you get too close to the clinical drug, and any change in the clinical drag will affect you, and you have others like the Dnd. Like models where
Guillermo Reynoso: the upper level classes uh those are low hanging fruit; and if any of you already know that there are ingredients or substances that you don't have either at the
Guillermo Reynoso: resize
Guillermo Reynoso: level or at the generic level uh of the base level Uh, that will help a lot to be able to sure to be sure that we have
Guillermo Reynoso: those substances populated, and we have some stability in in the in those Ids going forward.
Julie: I really would like to get consensus from the group. I think we have. We have all heard your view, and and in so many ways we do not disagree with you. We know we need better coverage of Mps. We know we need better coverage of Mp. Only is.
Julie: And actually, I have heard from you argued in a completely different context that we need better coverage of Cds. But we won't. Go there. What I would like to do for this group, please, is to to just find out whether,
Julie: firstly, the process that we are suggesting is something that you feel you could take part in,
Julie: and secondly, in it. We've done this, as I say at the moment at Cd. Um it. I don't think it would be very much work to take this back to Mp. Only an Mp. F. Only um, not least because we did that to start with, and just got a very few concepts uh honey is nodding. So so that's not a problem. If you would prefer to do that.
Julie: Um, please note as Emma said. Um. If we did only go for Mp. And Mpf. Only we will still need It's It's part of the the requirements that we have um from the content team. We will still need good supporting data,
Julie: and we will still need it from a a minimum of of three countries.
Julie: So i'm really like to know I don't know whether you want to vote or put something into the chat, saying, Yes, I I support cd so. Yes, I support Mps and Mp. Only is um, or actually this is nothing. This is not where I want to go at all. Um, because I've I've not heard from from the majority of you, Yet it's just it. Just we just need to know, because if this isn't helpful
Julie: um in a sense, we won't do it. We've It's here to serve you as as the the the user group that that the stakeholders, the population that um represents the clinicians and patients that we're we're trying to look after uh through our informatics. So um,
Julie: please,
Julie: either, you know, put something in the chat or put your hand up. Just so. We have some sense of a way to go forward.
Julie: Oh, not!
emma melhuish: And if you're not careful, I might pick on a couple of people
emma melhuish: just to clarify this process that we're looking at where we're going to put forward this one hundred and fifty, and then we're going to go through and say, yes, we've got it, and no, we not, or whatever. This is a an initial process to populate what's missing. And presumably once we've done all of that
emma melhuish: Um! There will be a less heavyweight process, as we
emma melhuish: add new things to our various national,
Julie: Absolutely, absolutely. This is just, you know, we here so much. We've got gaps. We've got gaps. We've got gaps. This is what we're trying to do to address those gaps, and if it's um yeah, it's, and if it's too heavyweight, we we can drop it. But um,
Julie: if we don't do something, all I think we will ever hear is gaps, and you know we all know
Julie: medicinal products change.
Julie: Um, you know, two years ago we didn't have Covid vaccines we have. Now. Um, we have to keep up with it. The gaps just get bigger and bigger. I see another hand. Thank you, Marta.
Marta Pavón: Hi! I'm Michael from the Nrc. For Spain. Hello, welcome! Uh, Thank you. Uh, thank you, Julian, and thank you, honey. Thank you, Monica,
Marta Pavón: and for for us it is much easier to work with them. Be only because we are already creating them currently in the extension when they are not in the in the international vision.
Marta Pavón: Um.
Marta Pavón: Every month at the Nrc. In Spain we identify the Mps and cities that correspond to the new address medicines, and we see if they are in the international edition. So we have identified the cities that we have needed each month, and have not found,
Marta Pavón: but we have not created them, because instead, we create a intermediate concept with the active substance, and and not the precise, of the active ingredient, and at the State's firm rover, not the manufacture of those form,
Marta Pavón: so it is much easier for us to work with them, and be only because we are already created them.
Julie: Yes, because you work with dcps rather than um with full chemical drugs, if I understand
Julie: um. But do you? Um? You said Np. Only, but your your Dcps would create Mpfs:
Marta Pavón: No, we are not created, and yes, you know, because at the those for me is is different. It's like basic those form. It's It's not the intended side of those.
Julie: Okay, Thank you. That's really helpful. Thank you.
Julie: Anybody else.
Hanne F. Johansen : Perhaps you might let you guys simmer it this a bit,
Hanne F. Johansen : and let us know that email or something.
Julie: That's a good idea what we plan to do. And and there's um We had um all sorts of other things to to talk about. Um, which we haven't done. Um, but what we have is a spreadsheet. We can share that at the moment it has the Cds. We could very easily, I think, honey, um add in just the Mps. And the Npf. So that you could actually look at those, and in a sense, see the difference. See the difference in volume,
Julie: and see if I see if what what you think um and I sorry I've lost. I think there's some some chats as well. I've I've missed those.
Julie: So Jerry says his instinct is to give the um the Cd proposal to try um, And
Julie: Yeah, I think we have to see what what Hannay has said is to give people a chance to think about it. So um, we will do that. We will offer you the two spreadsheets, and they will um the the two parts of the spreadsheet um based on that that link there.
Julie: Um Monica, I think we were going to go over to you to to suggestions for the next meeting.
Monica Harry: Yeah, that's just to say that we're going to alternate the timing, so that uh people in different hemispheres don't always have the anti social hours. So those are the times proposed. So eight Pm. In January That's utc um two hundred sorry, and then February would be eleven
Monica Harry: um hundred utc, so I i'll post the meetings in the calendar. I just want you to make people aware that that's the plan,
Julie: and what you would be very welcome to do. Um
Julie: is in a sense um this. The spreadsheet will be up. You are very welcome to to, in a sense, put some data in um if I just change my screen um
Julie: to show you
Julie: the spreadsheet itself, which I think Is that one there with any luck? Yes,
Julie: um!
Julie: This part here
Julie: can just be copy pasted to um to another part here, and you know you could, if you won't, see how much work it is to fill in,
Julie: and you know, if it took you three hours to do five Mps.
Julie: That tells us something.
Julie: Um, if it only takes you an hour to do twenty Mps. That also tells us something. Um, so it's. I think it's it's it's some important to to try, and and maybe at the this Um Thursday,
Julie: January the twenty sixth meeting we have, we can have some um sense of how we're going and and what it's like.
Julie: Um.
Julie: And yeah, let's see. And of course please do. I think we put our emails on this, and if we didn't, we can do. Please do email us with your thoughts or anything like that. I'm sorry I haven't got time to to read the chats. Now, um! I will catch up on that.
Julie: Thank you very much. Thank you, Julie. Honey. Thanks, everybody, and talk to you next time. And yeah, please do email or send in your thoughts, comments, etc. And I'm just having a quick look at the chats and it it, you know we've got different views. Let's see what's the best way of doing it.
Ana Paredes: Okay, Thank you very much. Bye, bye. Thank you.