Become a Creator today!Start creating today - Share your story with the world!
Start for free
00:00:00
00:00:01
eCTD 4.0 Pilots: Cleared for Takeoff!
69 Plays1 month ago
Diarmuid Waide, Regulatory Product Specialist here at Ennov, gives us a behind-the-scenes look at the EMA’s eCTD 4.0 pilot and what it revealed about the gap between theory and real-world readiness.
Our Top Resources
- Track key implementation deadlines: Explore the updated eCTD 4.0 timeline
- Know what’s changing and why it matters: Read the readiness guide
- Get everything in one place: Visit the eCTD 4.0 resource hub
Recommended
Transcript
Introduction to the Innovation Podcast
00:00:00
Speaker
Welcome to the Innovation Podcast, your go-to source for the latest trends, insight and expertise in life sciences and regulatory affairs, all in one place.
Experience with the EMA Pilot
00:00:10
Speaker
At Enove, we're dedicated to empowering life sciences organisations with innovative solutions to navigate the complexities of their industry.
00:00:17
Speaker
This time on Innovation, we've got our very first return guest. I'm delighted to welcome back Dermot Wade, who joined us earlier last year to talk about ECDD 4.0. Since then, he's been keeping himself busy with the EMA pilot. So he's here today to give us some feedback on how that went and the experiences of his clients and his own experience during that pilot session. Dermot, thanks for joining us again. Thanks very much, Charles. Pleasure to be here.
00:00:43
Speaker
So before we kick off, just for those people who maybe weren't listening to the last episode, and obviously they should definitely go back and catch up with that now, can you give us a little bit background on your experience and then also your role in this latest EMA pilot?
00:00:57
Speaker
Yeah, absolutely. So um previously, i was a publisher in industry for many years, working for CROs mostly for a couple of large pharmaceutical companies. So I've seen my fair share of the submissions.
00:01:12
Speaker
um because i i was brought into ENOV in order to be the interface between the customers and the developers in order to um better our tools, in order to make sure they are as comfortable and as flexible for our publishers and um their needs. And in this pilot, that's exactly um what it was utilized for.
00:01:31
Speaker
I would talk to the developers, ladies with them, over the new specifications and how the tool will be designed in order to help us um publish the EC4.0. Throughout the pilot, I was basically just giving my expertise to the clients, giving my expertise to the developers and ensuring a smooth process for everyone.
Success and Client Collaboration in the EMA Pilot
00:01:52
Speaker
So as I understand it, the pilot ran through the summer and the beginning of the autumn in 2025. How do you feel like that went overall? Just before I say hi, I went i just want to say um congratulations to all of the clients that participated in the pilot. um You guys really had the ground running.
00:02:10
Speaker
and Every client we had um was successful, which is great news. The collaboration between you all in order to um share your experiences, share your feedback with us, really, really made waves. And your success is testament to your effort and expertise, really.
00:02:30
Speaker
Yeah. And what um one team awa I want mention that doesn't really get a lot of credit um would be the internal team. You know, we had a way larger number of clients than we were expecting participating in this pilot. And I really appreciate all the effort the teams to set up them environments, set up all the infrastructure so that clients can use it just like they use their normal system.
00:02:49
Speaker
And then also the developers, um not just for their adaptability and all of the work they put into this pilot, but all of the preceding years and all of the effort they put into developing ECT 4.0 into what it is today.
00:03:05
Speaker
oh I mean, that's fantastic to hear. I think it really, it speaks to how excited people are about ECT 4.0 that we had so many clients kind of jump on that and say, i want to be involved in this pilot. I need to be a part of this.
Challenges and Learning in the Pilot Process
00:03:17
Speaker
this work to get ready for ECTD 4.0. I think that's always really gratifying to see.
00:03:23
Speaker
Definitely. Like even on a personal level, like the amount of clients we've seen wanting to take part in this client, obviously you use quite large loads of countries, loads of regions that people are all very much interested in.
00:03:35
Speaker
And it gave us, it gave me the opportunity really to interact directly with the clients, which is like probably the most important part of the work I do. And, What was quite inspiring was just seeing everyone ah come together in our group meetings with every client and everyone sharing their experiences, the issues they were having, the things that they found that worked well, the things that they found that didn't work well, sorry.
00:03:56
Speaker
It was really inspiring to see that. And yeah, um overall, very exciting to see the amount of effort that was put in by everyone and they were all rewarded with their successful submissions.
00:04:08
Speaker
Which is what we're all here hoping for. Definitely. So it sounds like the answer to the question, how do you feel like that went, is it went really well. Yeah, very, very good. And how do you think clients generally found it? Were there a lot of challenges that were maybe a bit unexpected? Did it run really smoothly? How was it?
00:04:27
Speaker
Yeah, so at the start, everyone was really eager. um like Everyone was really eager to get started. um We gave them their systems. um And then they realized, oh something's a wee bit different here. um Part of the package that we gave them, we gave them demos of the system, ideas on how to use these new features. And um I made a guide so that they would be able to kind of understand the new concepts and how to fill in the original metadata as it's needed in EC 4.0.
00:05:01
Speaker
but yeah they Overall, the the amount, how quickly the builder submissions was amazing. But obviously the new year things such as context of use, sender to find keywords, control vocabularies and stuff like that, um obviously provide ah a wee bit of a not an issue, but more like difficulty. Just that it's it's brand new. no No one's really experienced maybe a couple of larger clients maybe with Japan, but Overall, as a whole, we're all very new to using in practice rather than in theory.
00:05:30
Speaker
But overall, they gave us some very good feedback and they were very open in collaboration and everyone was speaking to each other, sharing experiences. It was very, very good. And yeah, everyone submitted successfully. So I guess everyone feels great about it.
00:05:46
Speaker
So did you find that gap between the kind of theory and the experience was maybe a little bit wider than you'd you'd been expecting? Yeah, it's it's hard for me because I'm seeing EC 4.0 every day. um I'm looking at submission units. I'm looking at the specifications. I'm seeing our tool. And I'm i'm seeing all of the engineering and behind the things that you know just it's one button on the screen for you. But I'm seeing all the processes behind that.
Addressing Validation Errors and Schema Specifications
00:06:13
Speaker
And going from that, and trying to abstract myself into the view of the publisher. you know Sometimes I forget what it's like. um But yeah, like that's we kind anticipated it.
00:06:26
Speaker
We tried to um set our clients up as best as possible with the demos and the documentation and stuff like that. um But yeah, it was but it was kind of just a wee shock to me. I was like, oh yeah, that obviously everyone doesn't know about this. like It's all brand new to the average publisher.
00:06:45
Speaker
um But yeah, it was quite a gap there. I think that's really... key, isn't it? Like often when we're working on something really regular regularly, and it is one of these kind of big changes like ECTD 4.0, we feel like we've read all the documents, we kind of understand the theory, we'll be good to go. And then when you get in there in practice,
00:07:08
Speaker
it's actually quite different. So I imagine that was one of the benefits of the pilot was that it gave people that chance to really start putting some of that theory into practice and start understanding how that's going to feel.
00:07:19
Speaker
Yeah. You know, how that's going to work when they start making their submissions. Yeah. Like, and we've seen it too, like there was challenges in this ah pilot, especially, um you know, all the clients are looking at the new XMLs and a lot of them are,
00:07:34
Speaker
first time users. you know We've only had maybe two or three of the bigger clients who previously participated in and Japan and US. So they might have some exposure. Some of the people who participated in them pilots may not be there anymore. And um you know generally, people haven't seen the new submission unit XML. They haven't come through it.
00:07:54
Speaker
And it is also not as user-friendly as the current EC3.2 one. So yeah, that's all new And that kind of ties into the bigger kind of problems we were having is people weren't sure what validation errors meant because we're all very used as to as publishers ec 3.2 and their validation criteria you know it's been the same for so generally whenever you open a validation report you see the error and you're like oh yeah i know what that is oh that's where it's located i'll go and have a look and uh maybe fix that but i found in the easy 4.0 pilot there was maybe a little bit of a disconnect there because people are going in they're like oh yeah i've just published my first submission then they look at the validation report and it's like oh there's something wrong there oh wait i don't know where to go i don't know how to fix that um so a lot of the questions that were coming in were regarding maybe validation criteria and stuff like that it's like oh this um for example the review id hasn't been filled in and
00:08:57
Speaker
They'd be like, oh, but where do I put that? Where do I do this? And stuff like that. So we'd just come back to them, maybe show them where in the like XML it was wrong or where they can update it in the system and
Strategies and Feedback in Pilot Participation
00:09:07
Speaker
stuff like that. And it was really um interesting to see how other publishers viewed the XML and the validation criteria and how the tool works versus how we internally would view And, you know, through collaboration, we're able to get a lot of their issues resolved and um get them sent away.
00:09:27
Speaker
Part of that too was that we had some issues regarding the schemas and the specifications and sometimes they don't always align. So I believe just off the top of my head, things like submission ID, by schema, it isn't there, but in the specification, it is there. So we designed it obviously by the specification and then we realized quickly, oh dear, it wasn't about to be here or it's invalid by schema.
00:09:54
Speaker
Yeah, so our developers obviously very, very good. They were able to go in, fix these things, get them changed quickly, and then our implementation team got them deployed to the client systems. And yeah, we were able to submit successfully.
00:10:07
Speaker
One other wee interesting challenge too was that when the pilot was first released, we had version one of Control Vocabularies. And funnily enough, they didn't contain EU as the reviewing country for a centralized procedure. So a lot of clients came asking, it's like, here, where's EU? Where's EU?
00:10:26
Speaker
But yeah, we just had to inform them that then versions of the CVs didn't have EU, but we were able to update them with the latest CVs. And eventually, they were able to submit to the EU.
00:10:37
Speaker
Bit of a gap for a European Medical Association pilot, that one. Yeah, that' ah absolutely. I guess that's the thing with the pilots is it's not just about as vendors learning or even about our clients learning. It's about the health authority learning as well. as And then kind of having that opportunity to road test things with real submissions and real users and and make those improvements.
00:11:00
Speaker
Oh yeah, absolutely. so I know that we had quite a range of clients, you know, from different business areas and of, of slightly different sizes participating. Did you find that everyone approached it in a similar way or were there different strategies that they used?
00:11:16
Speaker
Yeah. So, um, as a vendor, obviously participating pilot, we want everyone to do nice, we small submissions and send loads of them. So, but that didn't tend to be the case. Uh,
00:11:28
Speaker
With the larger, more experienced clients that maybe have done the EC 4.0 before, they tended to go down the initial MAA variation approach, quite chronological, quite normal. um But maybe with the smaller clients, we seem to see you know smaller sequences, but more of them.
00:11:45
Speaker
Both have their pros and cons. For example, going for a larger submission first when you're less experienced, you're more prone to make mistakes, and you're more prone to repeat them multiple times. So you know we all know MAAs take edges to build, and um especially EC 4.0 being new, there's lots of areas where you can miss optional keywords or required keywords and stuff like that. So there may have been potential reworks there where clients had to go back and fill in a load of data that they may have got first time around had they had done the smaller submission first and then
00:12:19
Speaker
had the experience for that. But then you know the smaller clients, they also had an advantage in terms of the smaller submissions because then if they made an error in the first one, they could quickly amend it for their second, third, fourth submission.
00:12:32
Speaker
And in terms of larger submissions too, you it's like if you have an issue with it, it's kind of blocking your subsequent sequences. So you're kind of getting your time frame pushed back and back and back. um Thankfully, that hasn't been an issue in the EU pilot because it keeps going.
00:12:47
Speaker
Yeah, strategies did vary, but it was good because the smaller clients or the smaller sequences, rather, it wasn't just small clients doing sequences like that, but they gave us the opportunity to fix things earlier in the pilot. So we had our first submission built pretty much the next day after the systems were given to them.
00:13:07
Speaker
Wow, that's really quick off the mark. Yeah, it was pretty pretty quick. Some clients um just want to get in there and get it done. um But that was good, though, because we got early feedback from them, which then in turn helped everyone else.
00:13:19
Speaker
Because if you're going with a bigger submission, you tend to compile all your questions into one giant list. And we might not see that to week the end of week one or midway through week two. But with the smaller clients, they come with a couple of questions, but they would be covering a lot of the larger questions.
00:13:35
Speaker
submission questions as well so it was handy to prepare us for any um troubleshooting that may came about after the fact yeah it sounds like in some ways it's not necessarily about as a client picking one strategy as as the best strategy but maybe working with the other people that you're piloting with to to pick a diversity of strategies so that you have that very that range that's being tested Yeah, definitely. And it's different use cases too for the tool. It shows you the scalability a of EC 4.0 for larger submissions in the system. And then it just shows you the efficiency of sending out the smaller ones.
00:14:11
Speaker
So what would you say to people who are listening to this who are maybe thinking about participating in future pilots? What would you recommend that they do? Yeah, for anyone listening, regardless of your tool or vendor, just make sure that if there's a country that you're interested in that are piloting the EC 4.0, that you definitely apply and try to get in it.
00:14:33
Speaker
I feel like the most important thing right now is that everyone in the industry gets as many submissions to the health authorities as possible so that we can have the most robust and comprehensive specifications so that we all can share our user experiences. And so that all the common questions and all the answers can be provided to us so that we can have a more smooth user experience, a smoother transition to ECD 4.0 and really work out the kinks.
00:15:03
Speaker
But like mainly what you're wanting pilot for is experience using your tool. um I alluded to it there in a previous answer where... you don't really know what you're doing until you try it. you you read You read the specifications, you may read a user guide, but until you do it in practice, it's kind of hard to put yourself in that situation. Yeah. um And especially with troubleshooting validation, um it's going to be your biggest time sink, or at least I think it's going to be the biggest time sink for smaller EC 4.0 submissions whenever people transition over.
00:15:40
Speaker
Just because we we we all don't have the experience of troubleshooting these things. EC 3.2, I've seen thousands of validation reports. I know the ins and outs all of them. I can generally get there pretty quickly. But with EC 4.0, there's even times I'm just sitting there like, hmm, I don't really know what's going on. The kind of classic, that's a great question, I'll get back to you moment, where you need to go away and have a think about it yourself. Yeah, 100%, 100%.
00:16:06
Speaker
You know, having had so much exposure to it and the XMLs and then how the system pulls your data into the XML, it really helped with trying to troubleshoot these validation questions. And you know you're only really going to get that experience by doing submissions and doing pilots, at least because it's lower stakes than live submissions, and doing that early so that your publishers are ready so they can share their experiences with maybe other companies, maybe within your own teams.
00:16:37
Speaker
And yeah, it's vitally important. One more massive benefit, and I'll be a little bit selfish here, is to your tool providers, being able to collaborate with them.
00:16:49
Speaker
Really, our objective is to make the tool as easy as possible for you to use and as functional as it can be. Going through this pilot, we've seen things that weren't particularly pleasant for the user, mainly around document type.
00:17:03
Speaker
and We would have it assigned on the folder level, which, as you can imagine, would require you to create multiple folders within folders for every single document type. And yeah study reports were quite interesting. but um As part of that, we quickly developed a solution for it.
00:17:19
Speaker
We are deploying it in our next release, which will be available to all clients. So yeah, it's really about that collaboration aspect. We need the feedback. you know There's only so many people here that can test one thing, but without doing enough live submissions. Throughout that pilot, you know we had maybe... 50, 60 people all building submissions at once doing multiple submissions. That's infinitely more volume and different viewpoints that we all we need to combine and use to implement and into our tools, um ultimately to make EC 4.0 as smooth as possible for the user and to get your submissions successfully sent to the relevant health authority.
00:18:02
Speaker
No, I think that's really key. You know, that that chance to get the hands-on experience that means that when you do your first real submission, this is a process that's already familiar to you. And also, like you say, you've had that input into your vendors tool. You've made sure that you understand it, they understand your needs and your perspectives, and hopefully they've adapted to those needs and perspectives. You know, I think pilots are such a fantastic opportunity
Future Pilots and Insights
00:18:28
Speaker
to do that. It's not often in the regulatory world that we get a chance to influence the way that health authority does something. So i think the more that we can seize those chances, the better.
00:18:38
Speaker
Yeah, absolutely. And this year, I believe there should be free coming up. So if you submit to Australia, Switzerland or Canada, now's your opportunity. Definitely take up.
00:18:52
Speaker
Well, thank you so much, Dermot. I found that really fascinating and I'm really excited to see what comes out of the next round of pilots as the ECTD 4.0 specifications and implementation and also the tools continue to develop.
00:19:07
Speaker
As always, we've got some great resources in the links in the episode description. So wherever you are, please do check those out. And thank you for joining us, Dermot.
00:19:17
Speaker
Thanks very much. It was a pleasure. Thanks for tuning in to the Innovation Podcast. At Inove, we help over 450 life sciences companies streamline compliance, enhance efficiency, and achieve their regulatory goals with our unified platform.
00:19:31
Speaker
Ready to learn more? Visit inove.com or connect with us on LinkedIn to see how we can help your organization succeed.