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The Challenge of Change Management
38 Plays13 days ago
Preeya Beczek, a regulatory affairs and compliance expert, joins us to discuss the practical challenges of change management and explore what it takes to implement it effectively.
Preeya’s Top Resources:
- Rethink change control across connected systems: Read the connected change control blog
- See real impact on regulatory productivity: Explore the Septodont case study
- Break down silos across teams and systems: Learn how to align quality and regulatory
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Transcript
Introduction to Innovation Podcast and Enove
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.
Change Management in Life Sciences: An Expert's View
00:00:18
Speaker
this time on an innovation, we're talking change management. Joining me is Priya Becek, regulatory affairs and compliance expert and managing director of Becek.com. Priya, I'm so glad you can join us. Can you give us a little bit of background on yourself?
00:00:31
Speaker
Yeah, thank you, Alice. It's lovely to be here. so sure. So I'm Priya Becek. I'm based in the UK. I've been independent for about 13 years now, working the regulatory and compliance space. And so What I tend to do is hands-on regulatory affairs works, especially critical phase project management for big submissions or critical submissions. And then on the other hand, I do a lot of ah infrastructure build with different companies, teams of different sizes, um helping them to you know implement or modernize their regulatory information management platform, develop or establish new or you know update processes. but also set up different operating models, look at roles and technology, you know, and how that impacts the roles and also governance framework. So really bringing all that together in terms of, you know, process system, governance, people aspect together. So, yeah, it's wonderful to be here. And I'm really happy that we're talking about this topic around the challenges of change management.
00:01:38
Speaker
Yeah. And I think what you said there about kind of your experience in bringing those processes and the systems and the people together, I think change management is just a perfect example of that because it's something that is really determined by that combination. You know, it's dictated by your processes, it's dictated by your systems, it's dictated by the people that you have involved.
Regulatory Burdens and Compliance Challenges
00:02:00
Speaker
So I think this is going to be fantastic. Yeah.
00:02:03
Speaker
um So just to start us off, I feel like we need to define the topic a little bit. So what do we mean when we talk about change management in regulatory? Yeah, it's a really good place to start, Alice. I think we need to make sure people understand that what we're talking about here is product lifecycle maintenance or what some companies call, know, licensed change management management.
00:02:26
Speaker
Absolutely. And I feel like it's something that dependent on the company's portfolio can either be a massive part of the regulatory burden, because if you've got established products, that is going to be the bulk of your regulatory burden.
00:02:40
Speaker
Or it may be something that is a smaller part because if they're focusing more on early development, but either way, it's something that really touches on, on the I would say almost every life sciences company has to deal with change management.
00:02:55
Speaker
Yeah, absolutely. And you're really very right in terms of the burden. You know, a lot of companies are, you know, putting lots of resources, technology, you know, at a global level to manage your product license. Because indeed, when you are a marketing authorization holder, you have to make sure your product on the market is kept up to date when changes come about. So there could be changes at the CMC level, safety signal level. and You might have a new indication. So that's also regarded as a change to the license. You might have new information coming in from, you know, patient centric data as well nowadays. So there's lots of things that can trigger a change for product license. And of course, in different countries or different regions, you have to abide by the different regulations on how to deal with that change. you know Some authorities will categorise the change for you and then give you the pathway to follow for that change, whereas other authorities, especially a national level in in some of the international markets, may not even have a written regulation about how to deal with that change. So there's many different challenges and at two extremes. Yeah, definitely. It's it's such a different challenge depending on where you have your products registered. Like you say, you know, in in say the EU, you have that really clearly defined path pathway. But certainly when we start talking about some of the, as you say, the in sort of international markets where there are less clearly defined pathways and there's more ways of valid ways of doing things,
00:04:37
Speaker
then you have that additional layer of complication, don't you?
Operational Challenges in Regulatory Changes
00:04:40
Speaker
Yeah, absolutely. And just to give you a couple of examples, I was working quite so many years ago now on ah a project that was a pure, what we would call a chemistry manufacturing and control, so CMC change.
00:04:53
Speaker
And at the forefront of it, you think, oh, well, this is quite simple because we're just changing our site from a to B or we're just doing a little bit of a technical equipment change.
00:05:04
Speaker
But then when you start to look at that in more detail and from a regulatory lens, there's so much that needs to be considered. you know Are we in a sterile environment? Do we need to upgrade our equipment? Does the equipment need to be bought in at a certain time when you're are you stopping manufacturing at that point? and What are the you know limits and specifications for the new machinery? and you know Does it need to be calibrated?
00:05:32
Speaker
What are the tolerance limits? You know, all this stuff that you would find in a chemistry manufacturing control part of your product dossier would need to be reviewed to see what's the impact. And then you've got the timing, right? you need to work backwards to say, OK, if we want to implement this new technology at our site X, Y and z how early in advance do we need to notify and and put our application into the health authority before we get the approval? And then we can actually switch from machinery A to B. So there's a lot of backward planning, you know, and all of that to be done. So it's really kind of quite a complex area about change. And so companies, large and small, will have their own challenges, Alice, right? So we we know that, you know, a small company might have challenges around resource. They may have quite an operating model that they are outsourcing work, you know, that to get support from different companies.
00:06:30
Speaker
you know, presence in the country and so on. and But also larger companies also have, you know, challenges because they might have high volume of products. So, you know, how the process of doing something might be very clear, but it's just the volume, the sheer volume of work they have might be high. So I think um and when you're talking about change management of a product, all of these things are the variables in that process really.
00:07:00
Speaker
Yes, I think that that point around the company size and the portfolio, they they have such a big impact on this challenge. I've worked in a a sort of range of companies and certainly when you're a small company, but perhaps you have only a few products, that can put you in quite a good position because you can really be hands-on with everything. Whereas you have an equally small company that might have quite a large and diverse portfolio of established brands,
00:07:30
Speaker
And they will have a completely different set of challenges or those big companies, you know, it's a big difference between whether you're a company with a few big blockbuster products or whether you're a generics company. So you might be huge, but actually you've got an enormous portfolio. It's all about volume and the challenges there are completely, completely different.
Impact of Company Size on Change Management
00:07:51
Speaker
And yet,
00:07:53
Speaker
I think all come down to those those similar factors of how do you combine the processes that you need, the systems that you need, and then getting people involved and making sure that you you're serving your your regulatory teams appropriately. Yeah, you've hit the nail on the head, Alice. I think you know one of the things I want to mention here is that that the challenge also is you know, downstream the in the in the thinking process here. Because at a regulation and guidance level, it's fixed, right? You can read the guidance down on paper and establish a process within your business based on that guidance or regulation. And therefore, the end-to-end change management process is really the same. you walk into a company, at the heart of it, the process will be the same, right? Because it's based on the regulation and guidance.
00:08:48
Speaker
Absolutely. i think you could probably take a work instruction from five different companies and play spot the difference and not necessarily come up with huge numbers, could you? Indeed, indeed. And so that you know that's not the variable. Yes, you've got the element that people need to understand, you know the guidance around do you tell and do, do you do and tell, do you submit and wait, you know what's the implementation, is there grace period, those sorts of things. Once you've understood those, you can work with your logistics and supply team to get that in place.
00:09:16
Speaker
And companies do this very well on the whole. I think where it starts to you know wobble a little bit, if you like, is where you've got you know the document level work and then the data level work. And that goes in your system. right So you know a lot of companies now, they you know have ah regulatory information management systems in place and they you know want to make sure that that's the authoritative source.
00:09:41
Speaker
And so... that's often where the challenge comes in because maybe people haven't used the tool before or they're, you know, what we call infrequent users. So they might use that system once a week, once a month. And so errors can come in. And then, of course, you've got the people element, language barriers, you know, geographical location, accessibility, you know, maybe people people in some countries you might know, of course, is that,
00:10:10
Speaker
that person in a one given country might be wearing three or four different hats. They might be a regulatory person, a medical affairs person, a quality person, and that, you know, compliance officer or one person, one man band. So you start to see challenges and variables creeping in here. yeah And so that's what leads to, you know, information being siloed in systems, information missing, Maybe people also have workarounds, they have this little spreadsheet or something that they're tracking their work and nobody else can really see it and understand the status of that work. And therefore you don't have a true picture on compliance.
00:10:50
Speaker
It's funny you should mention spreadsheets. I remember when I worked in a a centralized RIM team and I would, i get so frustrated with these spreadsheets that countries would send me, you know, they, I would just be thinking, why can't you just put this straight in the system?
00:11:06
Speaker
And um my next job, I then went and worked for a local regulatory team and immediately was like, oh, no, I see. I see. Because you are wearing so many hats. And actually, if that system isn't easy to use, if it is less effort to track it in a spreadsheet, that's sort of what ends up happening. So it was a really revealing moment to me as to why you get those those delays and those issues with siloed information if you aren't set up correctly right from the start.
00:11:38
Speaker
That's right, Alice, you're absolutely right. So i think there's so many things we could say about this and and how different companies are setting up their operating modules.
00:11:48
Speaker
You know, you had the whole, um you know, effect of kind of outsourcing or offshoring where, you know, companies started to put RIM systems into place and the current person who had the spreadsheet wouldn't think that entering that data into the system now is a new way of working. That would be split off onto a different role and then they would do the data entry. So now you've got this transaction to manage with another person who's entering your data for you. And actually what I find is people still maintain their spreadsheets. So you've got information in a spreadsheet and you've got to do this transactional management with the other person in another country, perhaps, who's now entering that data. Then it comes back to you to verify if you've entered the data correctly. And it just felt like a really bad workaround. Yeah.
00:12:36
Speaker
But we got over that. I think that era has passed. And what I'm starting to see in industry now is that that's coming back in, you know, regulatory leads, labelling leads, CMC leads, or the specialist or reg ops team. They are themselves entering that data and companies are starting to divvy up at what stage of the process who owns and therefore enters that data, right? So if you've got a change, You need to do the impact assessment to say, right, I've got this change. What's the impact? What do I need to create in my documentation? What's my regulatory strategy? That's kind of done by the regulatory lead or global regulatory lead. And then it goes off and then the submission management team or the RegOps team will go and plan that submission and go, oh, yeah, we need these 50 documents.
Role of RIM Systems in Change Management
00:13:23
Speaker
Here's my plan and here's the submission content plan, for example. And then it goes off at an operational level, you know, and people fulfill that. And then out it pops. Maybe it's ready for publishing or hand up to locals, local teams. And then, you know, submission is done. And then you've got that transactional information to enter as well, which is what date did we submit? What date did we get questions? What date did we get approval?
00:13:48
Speaker
And that kind of thing. And so then, you know, you've got this kind of layer, haven't You've got the strategic layer of a system. What's changing? What's the impact? Then you've got an operational level. You know, what are the dates in in out dates plus the documentation? And at some point that needs to go back up at a strategic level in some respects where you now need to make sure there's a handoff to your supply team, your packaging team or whoever to then implement that change.
00:14:17
Speaker
and I think companies have got this right 80% right I would say in that end-to-end flow what they struggle with is the handoff yeah you know and and and I think um hats off to any companies that have worked that out and they're running it like a oiled you know well-oiled machine but I noticed through my work that that little handoff bit is not yet working so as well as we'd like it to work I feel like that's really one of the core challenges of change management is that for cost reasons, for regulatory risk risk and compliance reasons, you need that process to run really efficiently.
00:14:57
Speaker
And actually by its nature, it's a process that involves an awful lot of people doing an awful lot of diverse tasks where any delays and any handovers that, you know, any of those transactional elements you're talking about that are delayed or don't go as smoothly as possible,
00:15:16
Speaker
really add up. And that's something that I've certainly seen where, you know, the quality are itching to implement a change because they know it can save money or it can reduce regulatory risk, or, you know, it may be a key key patient safety change.
00:15:33
Speaker
And they're not able to do that because they haven't yet got all the information they need, but actually that information does exist. It's just not in the right place yet. Absolutely right. And I think this is this this is why this challenge about having proper change management for a product in place and working smoothly, it really impacts companies, big or small, because it it just makes you question at first, you know, is this efficient? Is this process efficient?
00:16:03
Speaker
And like we said earlier, down on paper, it it looks efficient. It's when you start to bring in the workarounds and the people that that it starts to become inefficient. And if you don't set expectations correctly, it will continue to be inefficient at a level that actually people should be open to willing to understand and fix those inefficiencies.
00:16:27
Speaker
So there's got to be this understanding between, you know, senior level executives and the people tactics you do in the work, which are often, right, your reg ops team, your submission management team, your RIM team, your product information management team, That's where the the party's happening with the data entry and the document entry. and And I think if if there was a ah moment where companies were really embracing their RIM system and setting their expectations really well, then you you lower your risk of regulatory you know compliance and regulatory risk.
00:17:02
Speaker
I think the the time has passed now where regulatory teams are seen as the paper pushing people. I think times are now where regulatory affairs is a real partner in companies, they're really advising and other functions around them, you know, what is needed, why it's needed, how will the process work at the regulatory authority and what's the impact.
00:17:27
Speaker
So I think that there is this real shift in how regulatory affairs is viewed. And that can itself be very helpful in kind of keeping teams informed in a way that they understand right absolutely i certainly hope that we've seen that shift because it's yeah it can be seen as quite a administrative role but actually it's so it's so strategically important and particularly in this area of change management you know if you want
00:18:02
Speaker
to be able to make those changes to your manufacturing and streamline things in in the way that you need to, regulatory has to be strategically involved there and we'll be able to inform you you, know, given our portfolio, given our global reach and global presence, here's what that will look like. And that's going to play into the decision of whether some of these changes even make sense to go ahead with them anyway.
00:18:26
Speaker
Exactly. And I feel like it's good to talk a little bit about cost here, right? So at the forefront, you know, you've gone, you know, a team's gone into senior leadership and said, hey, we have a business case, we want to get a new system. Brilliant. That gets a little negotiation and it gets approved. We've put in a new system, spent two and a half years implementing a system, sometimes longer, and they cut they come away and they get asked a question in the corridor. Oh, so what's our return on investment for this system? Right, and I find that quite... ah
00:18:58
Speaker
ah you know challenging to answer. And I always think about it at two or three different levels. One is that, have you invested enough to make the system accessible by the people that need it? So if you've only given licenses to an you know headquarter team, but you want the country team to take responsibility, well, you haven't really got a very good return on investment because now you've got this manual step where the local person's emailing the central person And then the central person has to enter that data in.
00:19:30
Speaker
Yeah, that disconnect can kill you because people just don't, they don't see the value in the data often if they're not hands on with it. That's right. And so that person writing that email, and I'm going to get really operational here, they've just written that data in an email. So just put it in the system. Yeah. To me, that's a training gap and an understanding gap. right Then you've got the next layer of um governance, right? So are the leadership team asking the right questions and getting a report every month, every quarter on how many safety variations did we miss last month?
00:20:04
Speaker
I would be asking that question because that's a direct compliance gap. Yeah. It's about transparency, visibility and real time data. Right. So let's get let's use a system for that. To me, that's a return on investment because you're getting real time information, visibility.
Ensuring Success: Systems Accessibility and Governance
00:20:21
Speaker
If you're a line manager in the US or, you know, Europe or China or Madagascar, you're all going into the same system to look at the same information. I think that's powerful. um
00:20:35
Speaker
So I think there's always a little bit of a you know time needed to answer those sorts of ah ROI type questions because there needs to be an understanding of of that you know relationship between people, process, technology, governance, and then, okay, cost in the balance there.
00:20:52
Speaker
Absolutely. So we we've talked a bit about the challenges around change management and a little bit about the impact that that can have. But in your experience, what can companies really do to reduce those challenges?
00:21:11
Speaker
Yeah, you know what I'm going to say here. I
00:21:15
Speaker
i really believe that companies need to just take a pause when they're thinking about you know, um adopting good practices for change management and they should look at all elements. What's the process that we're following?
00:21:32
Speaker
Is it clear? Because like we said earlier, it's a fairly standard process, right? It's going to be the same regardless of what company you walk into. and But, you know, it's good to kind of, you know, pop that up on the wall first. Does everybody have the same understanding of the end-to-end process? And most regulatory processes, I write them all the time for companies, are 10 steps, give or take one or two. Okay.
00:22:00
Speaker
So let's put that process on the board on the board and just everybody come around it and go, yeah, we understand this as the end-to-end labelling process or the end-to-end you know product lifecycle change process or change management process. Yeah, we all agree. So that's the first thing, you know, to reduce the challenges that everyone has the same understandings. Then, of course, you know, the second thing and this is kind of fixed as well, is the system and tool, right? So make sure you're using a system that's kind of what I call unified.
00:22:31
Speaker
You know, does it, is, has it got a good flow to it? Is is it user friendly? um Is it innovative? You know, next year, if I want the system to do this as well, will it do it, right? What's what'ss what's the what's the room for making this system more and more um you know, friendly to what what I needed to do as a regulatory professional or a QMS person or a CMC person?
00:22:59
Speaker
And and how how does the system support my process? Absolutely. Have one without the other. and then Alice, I think, you know, this is almost building on what we said at the top of our chat here is that there's the people element, right? So You need to make sure that there's flexibility in the way that we can work with the system. and If you've got a unified platform, but different roles coming at that platform, that's brilliant. You're catering for all the different roles. If I'm a project manager, I'll be looking for something very different from a platform to a regulatory lead, to a submission manager or to a you know head of regulatory. So make sure there's flexibility on what it shows. And of course, that comes through dashboards, right? Powerful dashboards in in tools like this.
00:23:51
Speaker
and That gives you the ability to have oversight at a high, high level. You know, a manager might come along and go let me see, how do I work out the capacity of my team next year? oh I've got 200 submissions in my pipeline. OK, that gives me a view that I've got the right amount of people.
00:24:09
Speaker
and if people are entering that data, they're not going to be able to make that resource assessment. So oversight's important, but I think also then the quality of data in the system is also important. And that comes down to the people as well, setting expectations.
00:24:24
Speaker
It really does. And I think you've touched on such an important thing there with dashboards, because I often hear about data quality struggles and I've experienced data quality struggles.
00:24:35
Speaker
And for me, it often really comes down to, well, why why would someone care about the data what are they getting back from it is this just a job that they feel they have to do but they don't get any return on their investment you know we talked about return investment on investment in our whole solution level but actually on a really personal level as well yeah i think people have got to enjoy using the system yeah when you talk about user interface you know I want people to go into their project team meetings or asset team meetings, whatever you call them, and the submission manager, you know, opening their screen with the system or platform on their screen and entering information whilst they're in the meeting.
00:25:18
Speaker
Yeah. Because, you know, ideally, that's what you want to do. If somebody's talking about a certain change that's coming up, we'll so set up the draft event there and then in the meetings. why wait for the meeting minutes read the meeting minutes now you've got to talk to somebody because you need to interpret the meeting minutes oh and then suddenly now it's been a week since the change was identified versus being entered and triggered in the system so you know it's really being efficient but confident with the with the tool and to be confident it's got to be user friendly um in a very basic way um
00:25:52
Speaker
So yeah, I think that's going to be very important. And, and you know, and we could have another podcast about this, but data quality is so in the in the spotlight now, because you're going to be submitting data to health authorities. Absolutely. And I do think if you can show the value of that data to people, all of a sudden, they get very invested in data quality. And it makes life so much easier, um particularly if you are at that kind of reg ops level, where you're doing a lot of reporting on You know, we're missing data here. or I'm having to chase ah a local country person to get them to tell me what's happening with this variation there. yeah If you can demonstrate why that data matters to them and how that data will make their life easier. As you say, you can get people in a meeting to go, oh, we heard back from the authority. Brilliant. Let me just pop that in the system straight away.
00:26:42
Speaker
Yeah, indeed. I think it's got to be on the spot, you know, value. And then you've got a return investment because you've just saved a whole load of time.
Opportunities with AI and Automation
00:26:50
Speaker
For sure. and You know, and and I wouldn't even want to tell you sometimes I observe, you know, people having now another meeting about it, then another, you know, and where this would have taken probably 30 seconds to open a screen. And it's done by somebody who's a frequent user because they're in that meeting, they're in the mix.
00:27:10
Speaker
30 seconds versus, oh, now we've currently spent two hours over a period of a week to just put this information in. and Yeah, so it is it is one of those paradigm shifts and behaviour shifts that people, you know, are making and they need to continue to make that behavioural shift.
00:27:27
Speaker
And I think if we're talking about behavioral shifts and changes, one of those topics that's really on everyone's mind is how things like AI are going to assist us with that. So how AI can utilize data, which of course has to be high quality for it to be able to do that, to support processes. And I think change management is a great example here of a process that can be really supported by automation and by AI.
00:27:57
Speaker
Indeed, Alice. I mean, you know, you've you've asked the the buzzing question there. um i think that companies are already on their journey with automation and AI, right? That's for sure. and I myself has been working with ai and automation for the past three years, I would say, where companies are asking, you know, what's the best use cases?
00:28:19
Speaker
How do you judge whether this is going to be useful or not? You know, is there value add? You know, if we've got 10 ten use cases for AI along this end-to-end process where will it really pack a punch right so that kind of questions are coming all the time and I think that um first it's very important to define the difference between automation and ai um and you know my view and I'm sure there's other people's views out there but my view is that if you're using AI you're
00:28:52
Speaker
gathering information from internal and external sources to then have that information analyzed and then you get given an output which you then need to review if you're using automation it's a controlled set of information that's being converted from x to y so for example narratives to a csr signals detected to a you know signal report or psur entry so there's got to be um a little bit of a delineation between the two, which then allows you to put those use cases down on paper against your processes.
00:29:29
Speaker
um Some of the useful AI, you know, use cases that are being explored at the moment, they have to be based on regulation, right? So one of the one of the good use cases that I've come across recently is around, you know, you have,
00:29:47
Speaker
if if you then have regulations that are changing all the time, that creates a burden on, you know, quality teams because they have to now go in and review their standard operating procedures at maybe a lab level, GMP, GLP and GCP.
00:30:06
Speaker
um That's a big ask. So you're now going to a clinical team and saying, hey, clinical team, this regulation has changed. You need to update 10 SOPs. Whereas if you were using AI, maybe AI would tell you here's a new regulation and, you know, run it through your AI tool and it would then give you the gaps of what what's what needs updating the SAP, but also update the SAP for you and put yeah give you that output so that you can then review, right, okay, this is where my SAP needed updating. I've got some recommendations from my AI tool. Okay, just need to review and approve this SAP. So it saves quite some time on that assessment, you know, regulation and so on. So that's a really kind of nice use case. And I think another use case for AI, which is quite an obvious one, is, you know, um health authority interactions, questions from health authorities. How do you respond to these and how do you pick up what you did perhaps previously? So that's also quite a common use case. But I'm pretty sure, right, Alice, that there'll be lots of more use cases out there. It's just judging whether they are useful or not. Yeah, absolutely. i think that health authority one is one that I've been hearing about that idea for a really long time of, you know, you often get such similar questions from health authorities and how much time would it save if we could just go, oh Belgium have asked us this and actually France asked us the same thing three months ago.
00:31:39
Speaker
Let's just dig that out and resubmit it. But it's it's so challenging to have people who know every single question that's come in from a health authority. you know Often they've come to completely different teams. So that feels to me like, such a useful place where AI can step in and it can say, you know, you can use AI to analyze the the document that you've received from your health authority and then identify, well, here are the questions. And actually here are the similar questions from before. Here's how you answered them. So here's some places that you can start and then you can reduce your regulatory risk by making sure your answers are also consistent.
00:32:21
Speaker
which, you know, is is always a good thing. You don't want to be telling one health authority one thing and another health authority something slightly different if you can avoid that. Exactly. Yeah, I think this is really important to identify these sorts of use cases that are useful because otherwise a regulatory lead is going to be sitting there trying to contact two other reg leads to say, hey, did you get questions for this? You know, i want to see your answers. You know, that's a lot of valuable time wasted and so on. I think another good use case is kind of, you know, um label strategy.
00:32:55
Speaker
So, you know, if you're creating a new product for a particular indication, you've already got two or three other established products out there, you know, how do you review the e-part and the information publicly available for similar products or same indication, different, you know, different products, and how do you bring that information in so that you can compare, you know, things like pathology, claims, you know, you know, things like this in a very useful way, because I know for a fact, label leads or regulatory label leads spend a lot of time doing this manually. So it would be really cool if you could, you know, have an AI tool do that for you, tabulate it, tell you what's the highlight, that kind of thing.
00:33:38
Speaker
Well, thank you. I feel like we've dug into a whole range of different topics there. And hopefully people have found this as valuable as I certainly have. But Priya, if you were to leave people with your kind of three top tips, what would they be?
00:33:52
Speaker
Yeah, classic question. I love this. So I would say, and this is not in any order, Alice, but I would say, first of all, if you're ever embarking on, you know, doing any modernization,
00:34:04
Speaker
and you know, programs on change management and kind of really um revolutionising the way you do change management, I make it a cross-functional effort.
00:34:15
Speaker
and It should never be seen as a regulatory activity. It's an end-to-end, know, effort with, you safety, supply chain, clinical, you know, of course, regulatory, but also then, you know, further down the line, your logistics and packaging team and really you know, talk about that together as a cross-functional team. But also I would say, know, slightly related but also slightly separate is education. Education, education, education. So never assume somebody knows and understands what you know in your domain. And, you know, feel feel feel um
00:34:51
Speaker
comfortable to just tell people, hey, you know, did you know this? This is how it works. I think that's always underestimated. Absolutely. And I think that comes back to what you're saying about kind of getting those processes on the wall so that everyone really knows where everyone else is coming from. And sometimes you do that and you immediately see, oh my goodness, we could be doing this differently. We could be doing this differently. And it it's remarkable how useful that sort of exercise can be.
00:35:19
Speaker
Absolutely. And I think my final advice would be, you know, do do an assessment of your capability because often you may have given your workload to a you know to the headquarter or central team for many many years you know you think well this is all working really well but what about that local local local affiliates you know they're a gold mine of information and knowledge and relationship with the health authority and language and time zone there's so many benefits of utilizing local people and so how can you shift the balance a bit where you can take the load off your central team and push it out to your country's
00:35:57
Speaker
um And trust the process right you might need to educate them you might need to involve them in your cross functional conversations but do that you know go through that and then see whether you're going to get an uplift.
Top Tips for Improving Change Management
00:36:08
Speaker
In your you know use of your systems, you know compliance to your process and and therefore overall compliance for your products. Yeah.
00:36:19
Speaker
Brilliant. Thank you so much, Priya. It's been really brilliant talking to you and I'm so grateful to have had you here today. um As usual, we've got lots of resources available in our show notes and our description and lots more available on our LinkedIn as well. And of course, if you'd like to hear more from Priya, then her website is becek.com, which is B-E-C-Z-E-K.com.
00:36:44
Speaker
And once again, thank you, Priya, for joining us. Yeah, wonderful, Alice. It was great to join you. Thank you very much. Thanks for tuning into the Innovation Podcast. At Anove, we help over 450 life sciences companies streamline compliance, enhance efficiency and achieve their regulatory goals with our unified platform.
00:37:02
Speaker
Ready to learn more? Visit anove.com or connect with us on LinkedIn to see how we can help your organization succeed.