Marie Pihl

Marie Pihl’s journey from an assistant nurse with dreams of working in a children's hospital to becoming the Director of Operations, Technology, and Analytics in Global Patient Safety at AstraZeneca is nothing short of inspiring. Her story is one of perseverance, adaptability, and the power of commitment, as she balanced further education in molecular biology while raising three children. Marie's 21-year career at AstraZeneca, marked by pivotal experiences like training a vendor team in Budapest, showcases the transformative potential of embracing challenges and seizing opportunities.

Join us as we explore the shifting dynamics of career development in the pharmaceutical industry. With traditional linear career paths being reimagined, the importance of gaining broad experience and embracing lateral moves is more crucial than ever. We'll discuss how fostering a collaborative and open team environment can lead to immense growth and innovation, and the role social media plays in shaping career expectations. This episode also delves into the need for cross-functional understanding at organizations like AstraZeneca to ensure cohesive progress across various expert areas.

Finally, we uncover AstraZeneca’s strategic approach to vendor collaboration and oversight, emphasizing the balance between strategic control and operational efficiency. Through the analogy of a garden, we explore the continuous care required in pharmacovigilance and the cautious optimism surrounding the integration of automation and AI. Listen in for insights on maintaining adaptability, learning from setbacks, and the critical role human oversight plays in technological advancements, as we ponder the future landscape of pharmacovigilance.

Transcript

Speaker 1 0:16

Welcome to another episode of Innovation and the Future of Pharmacovigilance, a podcast series brought to you by Truliant Talks. I'm your host, indy Aluwalia, and I'm delighted to navigate the dynamic world of pharmacovigilance and risk management with you. But first a quick disclaimer the opinions expressed in this episode are solely those of the individual guests and do not necessarily reflect the official views of Truliant Consulting or their own company necessarily reflect the official views of Truliant Consulting or their own company. We're all about fostering insightful conversations here at Truliant Talks and we want you to know that any product, vendor or service mentioned does not imply an endorsement. If you're seeking professional advice for specific situations, we encourage you to go to our experts. Please remember this podcast content is meant for informational and educational purposes. Only Now, today, we have a fantastic guest with us. We have Marie Phil, who is Director of Operations, technology and Analytics in the Global Patient Safety at AstraZeneca, and she leads the ICSR process partnerships team as our guest speaker. Marie, thank you for joining me today.

Speaker 2 1:34

Thank you, happy to be here.

Speaker 1 1:37

So, marie, we always start with the same question here on the podcast, and it's a really simple one how did you get into PV?

Speaker 2 1:50

Yeah. So I think I ended up in PV by coincidence and I also ended up in pharma after sort of starting my work career in a very different area. So when I finished high school I was trained as an assistant nurse and my goal and ambition and interest was to work at the Children's Hospital in Gothenburg. And so when I was 18 years old and graduated, that's where I started. So I worked as an assistant nurse. I also had children very early, so I had three children within a few years and my latest child is born in 1994.

Speaker 2 2:46

And at that time I was sort of starting to think what would I like to do with my life and where should I go if I would decide to go in a different direction or pathway? And I live in Gothenburg and I've been passing the AstraZeneca office many times and thinking that maybe someday it would be very nice to be there and what would it take to get me there? I was also a bit interested in forensic medicine, so I started to think about chemistry, biology and in those areas. So when my youngest child was one years old, I realized that I first need to sort of upgrade my high school exam. So I did math in the evenings, and then I did a complementary graduation in high school so I covered sort of the basics in math and English and a few other subjects. Since I was aiming for university, I also had to do a scientific base course for a year and when I've done that I applied for a university. So I did molecular biology.

Speaker 2 4:09

So when I decided to sort of start my journey, I realized that I had at least six years of education to look forward with and I also had three small children Wow. But I started and I ended up in a class, and also actually I would like to highlight one of my classmates, because we were in a very similar situation and we tagged team and we managed to get through university in the four years that were expected. We both had small children, so we know how to sort of use every single opportunity to read and to train and to sort of learn in the area. I also was working weekends in the hospital, of course, because I had to have an income on the side, but I'm also in Sweden and we have a fantastic system, so I also got funding via different channels. So in the end I ended up doing my master thesis in AstraZeneca and then, of course that was my goal to to sort of get my foot into to the company.

Speaker 2 5:36

And when I did my university sort of, I realized maybe that I was not the person who would be happy in a lab. And since I have my background in medicine and children's nurse, it somehow became quite clear to me that moving into patient safety was an area that was both close to my heart and to my sort of education. So I applied for a position. I didn't hear anything we all know that recruitment in big pharma can take a long time and I graduated from high school and I actually had to go back to my old work. So I had to go back and work as an assistant nurse for about six months and then they called from AstraZeneca and wanted an interview. So I went to the interview and I got the job.

Speaker 2 6:38

So in 2003, I started my career at AstraZeneca and I've been with AstraZeneca since and I must say that, being part of such a big company, even though I've been here for 21 years, I've had many different jobs. So when I started I did case processing, but I also very early sort of showed that I was interested in leading people and more sort of personal matters. So after a few years I became line manager. So after a few years I became line manager. Case handling, as many people know, in pharma is a very sort of resource demanding activity. So most pharma are outsourcing. So during the time that was also the direction for AstraZeneca. So we decided to outsource case processing. So we picked a vendor and I think maybe AstraZeneca chose a slightly different way of handing over and ramping up Because we actually staffed up a team at the vendor location.

Speaker 1 8:06

Wow.

Speaker 2 8:06

So we had people at the vendor location in Europe in Budapest, for almost a year. So we were a few people going there from Sweden, including myself, and also from other case handling sites in AstraZeneca. So that was maybe the first big move for me in my career, because we know that we were supposed to be redundant.

Speaker 1 8:37

And.

Speaker 2 8:37

I was thinking that maybe it's a good idea not to sort of become redundant with 40 other people in the same area. So what can I do to maybe build on my capacity and capability and at least sort of maybe come home in a different time window? So I spent six months in Budapest training the new vendor, and that was, of course, a fantastic experience Working with colleagues from different sites in AstraZeneca but also building this new delivery service, because we were sort of training the basic and the new pool of resources. So I did that for six months and that was in 2009. And then it was time to come home and I was actually I didn't have a position. So I did apply for a few vacant positions and was again called for an interview in patient safety. So I managed to come back into a sort of different case. It was in the sort of more strategic operation area, so with periodic reports and surveillance, strategic operation area so with periodic reports and surveillance.

Speaker 2 10:07

But I actually did come back as a line manager and line management has been more or less a red thread for me. So I've been doing line management in surveillance periodics. I've been doing line management. I mean, in a big company there is a lot of reorganizations, so at one point we decided to divide the deliverables in early and late. And since I am a molecular biologist by training, then I was more interested in working in what we call translational, so early stage of development. So then I worked in that area for a few years, but at that time I think I've been working at AstraZeneca for almost 10 years and I did line management for a long time and we were again reorganizing. And every time that happens you need to think about what will be my next step and what will be my next move. And I think there are different ways to do career and it could be that you are sort of always aiming for the top, or it could be that you want to sort of use your previous experience and then maybe grow sideways, and I think that's have been more my style. So at that point I took an opportunity to work in regulatory for some time and I didn't know anything about regulatory. But they anyway wanted me because the leader of that department felt that I had such a long experience from change and line management and the new team they were creating had a lot of experts. So I teamed up with a colleague. She was an expert in regulatory and I think they saw me more as the most experienced people in change and line management. So we sort of led a team together, I would say, and we came with different strengths and capabilities and did that for some time.

Speaker 2 12:34

But I have felt that I sort of missed patient safety. So patient safety has been my home for almost my entire career. But I also felt that I needed a break from line management. So when I decided to go back to patient safety it was in a leading function but with no sort of responsibility in the line management area, so leading people or leading staff, but rather leading and deliverable. And I also went into sort of this vendor piece and I mean I did have experience from being a ramp up resource. So I came back and and then worked a lot with our vendor looking over the, I would say, four main safety service deliverables. So it was case handling, medical review, periodic report and safety services, but everything was focusing on vendor oversight, collaboration, sort of improvements in that area. So then I did that for a few years and then we decided to reorganize again. So at that point AstraZeneca decided to merge process and vendor management into the same function. So instead of covering a sort of broader scope of safety services, we were divided in smaller chunks, but in that chunk you also were responsible for the process piece and the vendor piece. So that's how I ended up in ICSR.

Speaker 2 14:29

So I mean, where I started with, case handling has been the backbone. I've always known our safety database, I've known the basics and then I've sort of built on to that sort of core capability in different ways. And currently I am working as a senior director. So I am leading a team of I think we are 17 people today, and in that capacity we have managed to work through COVID and all the challenges that came with COVID, when we had to relocate all our vendors and all the deliverables. You always need to ensure that you are compliant in this area, so that was, of of course, a great challenge.

Speaker 2 15:23

Then astrazeneca launched the vaccine and that also came with the challenges in the case handling space and the patient safety area and now recently we have, uh, decided to move from an homemade, home-built custom safety database. I think we were the latest sort of big pharma staying with the home-built system, now going into a more off-the-shelf system. So I think that's what we've been doing for the last two years planning for that. So, yeah, that's where I am today. We've now launched the new database and of course, it's an extremely busy time for us to ensure that we get in shape and get the system working and get down to sort of business as usual.

Speaker 2 16:27

But as a summary, I would say that sometimes it's been coincidence, sometimes it's been decisions that I've taken sort of deliberately, but I think I have always tried to use my previous knowledge and then build on that, and I've never been afraid to try both when it came to taking a decision to start university. And I mean, sometimes it feels that I started maybe in a slightly unusual order, having children and then going to university and then build a career. But I'm also hoping and I know that I have inspired people in my family and closest sort of friends that it's possible and it's worth it and I've never, never, ever regretted to to sort of starting university or or joining this big pharma, and I would say that every day I learn something new, and some sometimes are more.

Speaker 1 17:38

But um, yeah, you just hang in there I, I, I, I, I am completely fascinated by your career. It's, it's, it's um, to, to, to do all of that. So, from right, from the university's point that you made like to do that, to be in uni, to have kids, to be working part-time as well, knowing that you wanted to go to astrazeneca as well, which is, quite frankly, I, you know, I, if I were to choose a company and think, am I going to get there? I don't know if I could get there, but your fortitude and your sort of I wouldn't say arrogance it's not arrogance, but your one-track mind of that's what you want to do. You weren't quite sure what was going to happen, but you wanted to be there. It's just amazing. And I can see why people look at your career and say you well, if you could do it, maybe I could do it, um, but I think at the end of the day, it's, it's just a, it's, it's amazing and do you?

Diverse Career Paths and Team Synergy

Speaker 1 18:59

One of the things that, uh, we've talked about quite a bit in industry at the moment is that it's turned, especially since COVID. It's turned very siloed. So people who are at that point where they're trying to make decisions of where to go with their career I've spoken to people that think that the career path can only be linear, but you were saying as well that you prefer much more broad experience before moving up and you've kind of gone like sideways and up and then sideways and up throughout your career. What advice would you give to these sort of the the younger people right now, because I I think there is a a sense of one being a bit afraid to take risks and secondly, I think it's not very clear in this more sort of siloed age about what to do, and especially when remote working comes in as well, where you don't have necessarily the bigger picture of what's going on.

Speaker 2 20:13

I think that, and I mean my way of sort of thinking and sort of approaching things is sometimes very simple, but in a way, true, I'm thinking sometimes how on earth will I manage this? And then I'm thinking well, if I'm not, if I'm not the right person, who is? And this could sound maybe arrogant, but sometimes I'm thinking okay, I know what I know and as long as you feel confident in what your sort of capabilities are, I think that you need to try. And I've been working as a line manager and leader for a long time and I think that for us, the winning concept is that in my team I have people who are junior and middle and senior. There is very little prestige in our team because we know that when something hits us, we need to deliver together as a team. There's no such a thing as being senior or junior. Everyone is rolling up their sleeves in order to deliver. I think that we have also built an environment where you can ask everything, and it needs to be a very open and transparent and trustworthy environment, because that's, for me, is the only way you can learn. You need to feel confident in failing. You need to feel confident in trying and maybe knowing that I will not make this, I will not manage on my own, but I always have people who will be there to support and back me up. And I think that's been my way in sort of developing my team is that first you get quite a lot of handholding, then you try on your own and you check in and then finally you are ready. And pharma is not an area where you do quick careers in my mind, because it's such a complex area of working and you can be an expert in a small area, an expert in a small area, but then you need to start to understand how does this little area link into others and how do I get to understand the bigger picture? And that takes time and I think that if I should give any advice to maybe the younger generation is that it's a very I would think it's a challenging and difficult area to do a quick sort of career movement upwards.

Speaker 2 23:09

Also, I want to say that I think that doing career is not only just to reach a more senior position, because we are different. We are different in what is sort of our driver and what is our interest and what is our strength, and some people are experts and maybe their career is to dig deeper. Some people have a view of maybe climbing in a position and have more of a leadership capability, and some people find that it's a more appealing career to actually have one starting point and then broaden yourself. And I think that it's important that we acknowledge that all these three variations are different types of careers and it suits different kinds of people and, in the end, you need all of these categories in order to make a successful team, because you can't have a team of people who just want to sort of climb and do career. You need someone to take the lead and make sure you get the other people with you.

Speaker 2 24:29

But if you don't have experts who are there sort of digging and analyzing, and also the people who want to understand maybe the broader concept, I think then you will have a challenge overall in sort of developing and moving such a team forward and also ensuring that you have the right capabilities in the team. So, yeah, two advices Don't be afraid to jump, because I mean, yeah, it could go wrong. Hopefully no one will. I mean you will not be penalized for that. That's a way of learning. And then also, don't always look at the career to be upwards. It's also. There are other ways to do career, and that depends on your personality and your interest.

Speaker 1 25:27

Yeah, I think I don't know if it's and maybe this is going a bit too philosophical but I don't know if it's due to the fact of the way that social media portrays everything to be perfect that the newer generation are like well, no, it has to be perfect, it cannot fail. And I think your point about if it fails it fails At least you've learned something out of it I think that is a really fair point.

Speaker 2 25:57

And many times it's also an unknown area. So when you are moving forward you don't actually know what's right or wrong, and then you just need to I mean, trust your gut feeling, hopefully some of your experience, and then do what you think is best. But when I say you, I don't mean you as a single person, it's the combined you of the team and the joint capabilities so together you can make decisions to move forward. And that could be within your team, but equally well working cross-functionally, because in AstraZeneca we are divided in ICSR, periodic reports, signal management, risk management but in the end everything links together under sort of the GDP pharmacovigilance umbrella, and you need to understand that you are moving in the right direction with all those different sort of expert areas and not only looking at your own areas.

Speaker 1 27:07

That's a really fair point as well. To go back on something that you talked about, so AstraZeneca were obviously one of the early adopters of vendors. I think Maybe not the first, but certainly one of the early adopters of vendors. I think Maybe not the first, but certainly one of the early adopters. And you said that actually the way that AstraZeneca went about it was by making sure that the vendor were trained to AstraZeneca standards, rather than just being a vendor and outsourcing everything and just you know, there you go, you go, deal with it. Um, how did that decision come about? Because that at the time I mean now you kind of expect it, but at the time that must have been quite a shock to the system.

Collaborative Vendor Oversight in Pharmaceutical Industry

Speaker 2 27:55

The vendor probably weren't too happy either I at that time I was more sort of operational so I I mean I was not really part of the decision thinking and the strategic goals. But in AstraZeneca we have actually been very dedicated to keep the sort of oversight. And I know when we speak to vendors and when we have different interaction, you understand that they sort of come with a lot of expertises and they are willing to pick up most of the sort of deliverables and activities in the area. But having being part of I don't know how many inspections, have you been in in this area for such a long time? You have also been part of very, very many inspections of, I mean, bigger and smaller and from major authorities to smaller authorities, and I think that almost every time I think the question is how do you ensure that you have oversight of the deliverables?

Speaker 2 29:13

So I think that we've been from the beginning keeping that that the strategy comes with AstraZeneca. The operational deliverables is managed by our vendor. But we have also, with time, developed a very true I would say true partnership with the vendor we are working with, or the vendors, and for me that also comes with. It's not like we tell them what to do and they do it. I think that we tell them what we want and together we figure out how we do it, and that, I think, has also been a winning concept, because when I look at the vendors I work with, I see them definitely as an extended extension of my team, not as a vendor.

Speaker 2 30:08

We have experts with the vendors who support us in inspections. We have vendors in that area who can advise on more efficient way of working. So we are collaborating a lot. Of course, the majority of the of the sort of the vendor delivery is operational and and they do what we ask them to do. But I think that we have developed a very close relationship where we listen a lot on our vendor on how to best do things, because they have experience with other pharma and of course we are interested to hear if other pharma have found a smarter or simpler or more efficient way of working and we are open to listen to that.

Speaker 2 31:01

But we have never left the strategic pieces or sort of oversight of process. So how we interpret the regulatory framework, how we define it, we've kept that in-house. But then how we deliver it, I would say that is sort of an area where we are more collaborating. And then to do the final deliver, that is, with the vendor.

Speaker 2 31:30

I don't know if that answered your question but, um, it's been our model from the beginning that we set the strategic direction and then we sort of find a way to get there, and what I was going to say is that it's been quite a lot of inspections where we have been asked on how we can prove oversight, how we can prove the overall responsibility, the accountability, how we can prove the overall responsibility, the accountability. And we have been able to prove that because we can sort of show that the overarching elements are managed by AstraZeneca and then in the collaboration, and I think that's given us the confidence that we also know what's going on and that's how we want to have it how um so um with you know you've been involved in a lot of these change projects as well.

Speaker 1 32:29

Um, have you ever been I'm sure there are people out there that are thinking similar but have you been in a situation where the change is not going well and that you know, quite frankly, you're? You're there thinking do we can this change or or not? Um, I mean, this could be internal or external, but have you been in that situation where you just actually we need to make a decision and stop this right now?

Speaker 2 33:02

we actually have.

Speaker 2 33:05

So when I would say that in all these change of initiatives and I think you have that feeling multiple times Sometimes you know that there is no way back.

Speaker 2 33:26

You just need to make sure that it works, and that could be more or less challenging. But we did have an occasion when we were developing the vaccine and of course we had huge inflow of case reports ICSRs and we had to find ways to deal with that and we had multiple activities, but one of the activities was to see if we could maybe utilize a different database, not necessarily replacing it wasn't definitely the time to replace the database but if we could have something complementary that could give us more automation. So we had a develop initiative with one of the sort of system developers and I think we collaborated for almost two years with them and we launched it, and then we actually stopped that and went back to our in-house system because we were not, we did not feel that the system delivered the quality and technology that we were expecting, and that was, of course, a very difficult decision after two years of developing something and then deciding to actually close it down and and move back.

Speaker 1 35:06

So it happened and that was a very yeah but that that is, uh, I mean, that's a that's a very strong statement that you know you experimented and then suddenly stopped. And I'm guessing there's a lot of times within these change projects where you're probably thinking that, like, you're in the middle of a change project and I don't know, know, the vendor or something's really annoyed you and you're, and you're thinking, right, let's just like. The automatic reaction sometimes is, let's just can this? Now, how do you get through those motions, through a change project? Like, how do you then, um, make sure that it is a successful outcome for you?

Navigating Change in Pharmacovigilance Operations

Speaker 2 36:02

yeah, I mean that's a very difficult question because in the end it's very I I mean it's more like sort of sighing into the future to see if it will be successful or not. I think that you most of the time it works. It could be hard work and a lot of work and a lot of frustration, but you anyway feel that there is something there that we can build on then and we have a common goal, a common objective, a common understanding. And I would say that of course there has been ups and downs in the vendor collaboration. I think what we have learned is that you can't sort of think that we are now in a good place and and now it works well, so now we can sort of leave it and it's sort of operating on its own, so we focus on something else. Then you realize and I'm using the analogy of a garden, because you can have a very nice garden with the flowers and straight lines and no weed, but if you don't maintain it and give it time and love and that it needs, it's quite quickly sort of weed takes over. So I think that it's not like a, it's a constant work. It takes a lot to sort of get it in shape. And then you need to make sure you have the right reasons to maintain that, and it's much better to maintain it in a decent way or thinking that we can leave that for now and they manage on their own and we do something else and come back. And so I think that has been actually one learning, because in times where you need to do tough priorities, you may think that you can set things aside, and so I don't. I think that's a learning and to make sure that you still always maintain the sort of momentum.

Speaker 2 38:06

But then also I said in the beginning that we have recently moved into a new database. I mean, that's not working. That's not a straight way forward. There are a lot of challenges, it's a lot of frustration, it's a lot of people involved, and sometimes you think that can we just sort of leave this and go back? But I mean, first of all, I don't think we have an alternative this time.

Speaker 2 38:37

I think we have an alternative this time, but I also think that there is a different operation around it. So I know that in the end we will be successful, because people are engaged, they are competent, they are understanding the criticality. It's a lot, and right now it feels overwhelming, but when you anyway feel that the people who are collaborating have the right mindset and the right tools and the right competencies, I sort of believe that we will get there in the end. And I think I just need to trust the journey sort of. And I mean there change could be so many things. It could be changing an organization, changing job, changing a system, changing a vendor. You go through the same phases, but after some time you also know that, yes, there will be ups and there will be downs and in the end it will be stable state.

Speaker 1 40:01

And I think also to trust the process, yeah I, I think that change yeah, I, I think, I, I think that's such a good way of of thinking and, and you're right, you know, you, you guys, are going, still going through, even though it's it's it's, it's alive. Um, you are going through a major change like this is not a simple I don't know. Uh, let's change from writing on a piece of paper to, you know, putting it in a spreadsheet. This is, this is massive changes.

Speaker 1 40:39

Um, and the one thing I I liked about your garden analogy and I, I'm just going to bring this in um, because I was thinking recently about, uh, again, ai, ai is what everyone's talking about. Um, but your analogy of a garden I might have to take, because that also applies to ai. It's like, yeah, you could, you can change the process completely and have it all automated, but who's managing that automation? Who is actually looking to make sure that what it's supposed to be doing is actually the correct thing to be doing? Who's, you know, making those little trims to their, to the hedges, to make sure that they're not growing uncontrollably? Or? My garden is an absolute state. But, yeah, I, I, I fully appreciate that thought.

Speaker 1 41:36

Um, now we've come to close to the end of the podcast and I always ask um a question at the end, and this podcast is called innovation and the future of pharmacovigilance. Now I wanted to get your thoughts on what do you think the future is like where what's going to happen to a pv department, what's going to happen to operations um and what's going to happen to vendors actually to to vendor um now? Is that working still the way that it was supposed to work before? Is technology going to take over? What are your thoughts?

Speaker 2 42:21

my very personal thought and opinion is that I think that we've been talking about automation for a very, very long time, but I also think that sometimes we look at automation in very different ways and there are big consortia and collaboration frameworks and networks in TV where you every year is sort of talking about how much you automate and what's automation for you and where are we going. And I think that we had this home built tool old on. We had this home-built tool old on a platform that we know couldn't survive forever. And then we move into newer technology, cloud-based, and I must admit that I am surprised about the automation and technology we had in this home-built tool. We thought that it was quite a manual tool, but when you look at it and realize that there were a lot of decisions that were made, but it's so, automation could be from the sort of simple. So automation could be from the sort of simple, I mean you can have different tools or bots that are operating on top. You can have some rule-based learning, you can have some more maybe intelligent learning, but I mean the more complex it gets, the more challenging I think it gets, and I've been. I mean I was recently at the Drug Safety World Conference and everyone is talking about AI and in every session you look at these nights' presentation about what's coming and how the world is moving. But sometimes it feels like that I'm sort of I'm not questioning that it will come and we will get there, but I'm sort of wondering more when, because we talk about it and we've been talking about it for years and I think that when we say automation, we think that it will be like a case comes in and it goes out and you don't do anything and you save all these manual resources and everyone is happy and cost is going down. But ai, to your point, that also needs oversight because I mean the rule-based learning that's not. I mean that's an easy win and an easy thing to implement.

Speaker 2 45:21

But when you start to sort of use these more intelligent artificial learnings, you need to understand if that thing is taking the right decision and the more it learn, is it learning the right things? Are we feeding it with the right references or sort of decision points? And I would not be confident in letting it go away, because I think we are moving resources from manual, hands-on input to ensuring that the tool is operating in the correct way. Is the output what we were expecting from the input? Were the decisions right? And I think that when I hear the regulators, it's nice with automation and that's maybe the only solution for us, because there will be increased case volumes. We can't solve that with adding more people. We need to find other ways that are more efficient. But you also then need to be able to prove how your tool is behaving, how it's learning, how it's executing, and sometimes I don't even know if we know what's happening. So it it's a gray area.

Speaker 2 46:50

I also think that the pharma industry is very keen to make efficiencies and find I mean more innovative ways of doing.

Speaker 2 47:01

I don't necessarily think that the regulatory framework is there yet, so I think we definitely need to collaborate. So I think that what we have seen the last couple of years is actually that the regulatory agencies across the world is not going into a more standardized, harmonized way of looking at the framework. I think that we see all these small sort of specifics or deviations, so each and every regulatory authority would like things in a slightly different way, and in a big global pharma, it's getting more or less impossible to meet all these. You have one global database, but you have all these local deviations and I think that's extremely challenging and I would hope that somehow, if we can come together both pharma and agencies to understand that we need to have a more standardized, harmonized way of looking at PV, at the sort of the management of the different areas, so that we can see efficiencies, because it's very difficult to be automated and efficient when you don't have a standardized framework as your reference.

Speaker 1 48:33

I think that's again a fantastic point. Marie, it's been fantastic having you on the podcast today. Thank you so much for joining us.

Speaker 2 48:46

Thank you. Thank you, I'm out.