Transcript
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. At Enove, we're dedicated to empowering life sciences organisations with innovative solutions to navigate the complexities of their industry.
Speaker: I'm your host, Alice, and I've worked in regulatory operations for eight years. My background is in regulatory information management, and I bring my experience working in large pharmaceutical companies to supporting clients here at Enove.
Speaker: This time on an innovation, I'm delighted to introduce Paul Palmer, a pharmaceutical consultant, qualified person, and the director of Pharma Quality Services Limited. Also joining us is David Kalb, associate technical solution director here at Enove.
Speaker: Paul and David are joining me to discuss that all important relationship between regulatory and quality. We'll discuss why a strong regulatory quality relationship is so important, what can go wrong when silos separate our teams, and how companies can build strong working relationships between the two departments.
Speaker: And in the second half of the episode, we'll talk you through some of the most impactful regulatory updates of 2025 so far. Paul, David, welcome to innovation. ah Can you introduce yourselves?
Speaker: Paul, do you want to kick us off? hi Yes, of course. I've been in the pharmaceutical industry now for almost four decades. I've got master's in quality management, and another master's and business administration,
Speaker: I've been a qualified person since 2004, as well as being a responsible person and responsible person for import here in the UK. I'm a technical specialist. I ah do enjoy ah technical side of of business, of manufacturing, especially microbiology, including sterilization.
Speaker: And enjoy digital technology to to enhance performance, as well as a bit of personal biohacking. I've got a wide range of experience, again, not only from the companies that I support, but also from auditing.
Speaker: As a supplier auditor since 1998, I've seen such a wide variety of approaches to compliance within GXP that I use that experience to think naturally, often identifying the solution others haven't considered.
Speaker: Brilliant. Thank you, Paul. And David? Thanks, Alice. I've spent the last 25 years teaching adults how to effectively use software applications in healthcare care and life science industries.
Speaker: I joined Liquint over 17 years ago and became part of a NOV when they purchased Calix. I spent the first nine years training students and creating course materials to teach clients how to publish dcd ECTD, easy he for me to say, submissions and manage all aspects of product registrations.
Speaker: Over the course of the last eight years, I've worked as a solutions consultant, helping prospective clients find solutions to their regulatory information needs. Paul, I've worked for a number of pharmaceutical companies, and although in every company I've worked really closely with the quality teams, that relationship has also looked really different in every single company.
Speaker: um You've worked, obviously, with loads of different companies over your career. In your experience, what's that kind of traditional regulatory quality relationship look like? Well, as you said, it's it's different for every company.
Speaker: But traditionally, each team has its own processes, tools, reporting lines, usually only joining when it gets to the top at the senior level, maybe in the directors. For example, I worked for a company where the quality management system was implemented for quality and operations.
Speaker: But there was a completely separate regulatory system for filings. The team worked in a different building. They didn't even talk to the quality team most of the time. This made it extremely difficult to work together.
Speaker: To address this, we set up a new section for compliance within the quality department and based them with the regulatory team so that they could work together because the systems we were both using were completely separate.
Speaker: Yeah, that definitely rings true to my experience. I think in many companies, you have the regulatory people and the quality people, and the two don't necessarily you know overlap at all. And certainly the systems they're using often don't overlap.
Speaker: Yeah. Historically, I'd agree. But the way things are working now, the expectation is different. The regulators expect you to be working together. They expect the shared data. They expect the updates to be working towards the same goals, the same objectives.
Speaker: But also, just as important, have the same the key performance indicators integrated between the teams. Job functions at the senior level have changed in that they often cover both.
Speaker: So regulatory and quality director, regulatory and quality, regulatory and compliance, quality and compliance. But often you still find that they sit separately at the shopper level.
Speaker: There's now an expectation that teams function as a single unit with aligned goals and objectives. But the way that you see that is they're actually managed as one. Rather than having the siloed teams that just go up one reporting line, you often find on the shop floor level, especially when something is being manufactured,
Speaker: that you have a metrics management method. Rather than just being a silo and a single direct line up, you'll find that one person maybe has three or four different managers that they report into.
Speaker: It means you can work closely together, but it also makes things complicated. Yeah, it sounds like it really could do. um You talked there about how that's changed over time and that those expectations have really shifted.
Speaker: What do you think driven that change? Well, the traditional silo approach does have disadvantages. I've seen the ball dropped when things didn't get done. For example, there was a risk that was identified during an FDA inspection.
Speaker: Now, what I would say is that the quality team were always looking at where they were going to go next. We had the back room. We had the representatives in the back room from all teams, and everybody was giving their input. We noticed during the inspection that it was likely that they were going to go and look at all the subcontracted activities that we had.
Speaker: And when we looked at what they might want to investigate, what they might want to look further into, we found that we didn't have anything in place. The regulatory responsibilities included agreeing the specification for offsite manufactured product and to put the technical agreements in place, but none of them had been done. They'd been sent, but nobody followed up to make sure that they're actually implemented.
Speaker: The QA release at that time was being completed, but without these agreements in place. But now you'll find that this activity is traditionally a quality role. Yeah. And I think that thing of like quality assumes regulatory is doing it. Regulatory assumes quality is doing it. And in the end of the day, like you say, that ball just doesn't get caught.
Speaker: um And of course, although we've got our own strengths and, you know, our own specific qualifications and areas of responsibility, we're all working towards those same goals. Yes, exactly we are.
Speaker: But without the strong relationship, you can't achieve the goals because if you don't agree the direction you're going in, then the chances are you're going to pull in different directions. For example, I remember joining in a company where the quality teams were on one site, regulatory on another, and corporate in another country completely.
Speaker: I took on the role of aligning the systems, processes, and the teams to get them to work together. I found there was a significant lack of understanding across departments, across the teams, and of course, across the sites.
Speaker: To address that, I created and delivered specific training, which we later incorporated into the learning management systems to ensure the improvements will be maintained over time, not just a one-off solution.
Speaker: And I think that's so critical to kind of make sure that If you are improving things, you're embedding those improvements because those improvements are really, you've got those pragmatic drivers of of quality of patient safety, and also of course, efficiency.
Speaker: Absolutely. ah strong relationship between quality and regulatory offers many advantages. When we aligned the different areas, as mentioned before, we reduced the overdue complaints by years.
Speaker: We implemented regulatory changes on time, including safety updates, protecting the patient and ensuring compliance with current regulations. And of course, at the heart of that strong relationship are the tools and the processes that kind of facilitate our work together and make those improvements possible.
Speaker: So I know that having siloed data and tools, it it just makes things so much harder. I remember once I had to try and take a change assessment that quality had produced. So they told me, you know, which products in which countries are going to be impacted by a CMC change.
Speaker: And they needed me to work out which licenses that was going to impact. And you'd think that'd be really simple, right? But we had totally different definitions of product. And I think we even had different definitions of manufacturing site. yeah So it just took forever.
Speaker: That's a really good example, quite a classic. So worked for a company where um we couldn't even agree what GDP meant across different sites. But if as we go back to the tools, if the tools aren't integrated, if your data incompatible, when you try and transfer it from one location to another, you'll find that it fails on receipt.
Speaker: You'll find that the validation activities that you try and put in place never work. It's really hard to work together effectively if you don't have integration. It's really important to consider how information moves through a process.
Speaker: Make sure that the teams that you've got in place have the support they need to work together seamlessly without duplicating effort, but also without creating things that don't match.
Speaker: um going to jump in here. we We've definitely seen a focus on integration or better yet, unification of tools grow over the last decade or so. I see a lot of customers who are looking for a platform solution now exactly because they want to make sure that their teams are working together closely and their systems are supporting that collaboration, cooperation, rather than adding friction by maintaining those siloed approaches we've been talking about.
Speaker: Yes, absolutely. I've actually been involved in the implementation of a number of different systems with exactly that goal. So as the quality representative, I found that platform solutions are really critical to that.
Speaker: It's really important to think about what solution you're looking at and what it actually means. For example, is the vendor really offering different tools but with similar user interfaces and built-in connectors?
Speaker: Or is it really a unified platform where there's only one login and the data is all in a common repository? Don't expect to understand how it's working just by a quick demo.
Speaker: you actually have to ask the question, is this a unified platform? Because often you'll find that they've just built an interface that transfers data from one to the next. And of course that offers opportunities for automation and reporting, particularly for things like AI, which is really kind of exciting to me, where having common data can really help you implement AI tools with broader opportunities and and expectations.
Speaker: So on to some of the most impactful regulatory changes we've seen in 2025, and it's certainly been a busy a year. So we started the year and indeed we started this podcast talking about ECTD 4.0.
Speaker: David, I understand there's been some progress in the pilots that EMA are running. Yeah, that's right. The EMA have been running a limited pilot with vendors accepting ECTD 4.0 submissions.
Speaker: In fact, I'm really pleased to say that we've made a successful submission in that pilot already. Oh, that's fantastic. Yes, we're very pleased. Although, of course, there's a lot more work to do. The EMA have told us they're continuing to test.
Speaker: ah They may expand the pilot to other scenarios so that they can further clarify their requirements. Hopefully, that will lead to the next phase of piloting soon, where marketing authorization holders can begin making pilot submissions too.
Speaker: And of course, that's what's going to give m MAHs that really key experience preparing and submitting an ECTD 4.0. So it sounds like there's plenty more to come in the second half of the year. There sure is.
Speaker: And of course, we shouldn't forget about ECTD 3.2.2, because I believe quite a few countries have implemented ECTD for the first time so far this year. Absolutely. Ukraine, Kuwait, and the World Health Organization have all implemented ECTD ect submissions this year on a voluntary basis to begin with.
Speaker: Ukraine will make ECTD mandatory in August, Kuwait's looking for September, and the WHO in April of next year. There have been a few delays in other regions as well.
Speaker: Tunisia has postponed their implementation of ECTD. We hope to have an updated timeline from the agency before long. Singapore has also pushed back their timelines. They'll now accept submissions on a voluntary basis in April 2026, but we don't have a mandatory date yet.
Speaker: so it sounds like there's lots to keep an eye on there. How do you recommend companies stay up to date on those timelines? That's one of the best questions I've heard all day. I'd always recommend someone at your company monitor health authority websites for the most current information, but also be sure to reach out to your publishing tool vendor and make sure they are monitoring timelines as well and are ready to support you well before mandatory deadlines arrive.
Speaker: Thank you so much, guys. And then thank you so much, Paul. So you can find Paul at pqs.ltd or academypharmaceuticalexcellence.com. And of course, don't forget to check out our resources with more information about how you can build that strong regulatory quality relationship and what kind of tools you'll need to do that.
Speaker: 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 our unified platform.
Speaker: Ready to learn more? Visit inove.com or connect with us on LinkedIn to see how we can help your organization succeed.
