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00:00:01
Beyond Silos: Unifying Quality & Regulatory
16 Plays1 day ago
Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Paul Palmer, pharmaceutical consultant and Director at Pharma Quality Services, and David Kalb, Associate Technical Solution Director here at Ennov.
Together, we explore two timely questions: how can Regulatory and Quality work better together, and what 2025 regulatory updates should you be paying attention to?
Our top resources:
> Replace silos with a unified ecosystem: Read the case study
> Plan your next system upgrade: See 2025 RIM & QMS best practices
> Why unified beats “integrated”: Read the platform comparison blog
> Looking to streamline operations? Download the Unified RIM & QMS white paper
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Transcript
Introduction and Podcast Overview
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. At Enove, we're dedicated to empowering life sciences organisations with innovative solutions to navigate the complexities of their industry.
Host and Guest Introductions
00:00:19
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.
00:00:31
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.
00:00:44
Speaker
Paul and David are joining me to discuss that all important relationship between regulatory and quality.
Podcast Agenda: Regulatory and Quality
00:00:50
Speaker
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.
00:01:01
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
Expertise of Paul Palmer and David Kalb
00:01:10
Speaker
innovation. ah Can you introduce yourselves?
00:01:12
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,
00:01:25
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.
00:01:45
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.
00:01:57
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.
00:02:11
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.
00:02:22
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.
00:02:41
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.
Challenges in Regulatory and Quality Integration
00:02:51
Speaker
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.
00:03:00
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.
00:03:14
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.
00:03:29
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.
00:03:41
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.
00:03:53
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.
00:04:04
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.
00:04:19
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.
00:04:31
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.
00:04:43
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,
00:05:04
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.
00:05:15
Speaker
It means you can work closely together, but it also makes things complicated.
Advantages of Integrated Teams
00:05:20
Speaker
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.
00:05:27
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.
00:05:42
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.
00:06:00
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.
00:06:24
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.
00:06:44
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.
00:06:55
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.
00:07:12
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.
00:07:24
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.
00:07:36
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.
00:07:51
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.
00:08:02
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.
00:08:21
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.
00:08:35
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.
00:08:47
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.
00:09:09
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.
The Role of Unified Data and AI in Collaboration
00:09:22
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.
00:09:35
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.
00:10:01
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.
00:10:15
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?
00:10:27
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.
00:10:38
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.
ECTD 4.0 and Future Regulatory Changes
00:11:12
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.
00:11:24
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.
00:11:37
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.
00:11:50
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.
00:12:04
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.
00:12:16
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.
00:12:40
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.
00:12:50
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.
Closing and Resources
00:13:07
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.
00:13:31
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.
00:13:49
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.
00:14:00
Speaker
Ready to learn more? Visit inove.com or connect with us on LinkedIn to see how we can help your organization succeed.