Innovation and the Future of Pharmacovigilance

Rishi Chopra

Indy Ahluwalia Season 2 Episode 2

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Embark on an insightful exploration of pharmacovigilance with me, Indy Ahluwalia, as I sit down with industry trailblazer Rishi Chopra on Truliant Talks. Witness the fascinating narrative of Rishi's transition from biochemistry academia to becoming an instrumental figure in the pharmacovigilance space. His candid recount of the early days at Roche, where a nurturing community played a crucial role in his growth, sets the stage for a discussion full of personal anecdotes and pivotal moments that define a career. We delve into the essence of mentorship and the power of connections that transcend roles, highlighting Rishi's journey from his initial foray into the field to his current influential position.

Prepare to be inspired as Rishi unfolds the map of his leadership voyage, from establishing compliance frameworks to lecturing at universities, blending academic rigor with invaluable industry experience. His tales from the trenches at Otsuka, Biogen, and now CSL showcase the continuous learning and the unyielding pursuit of patient safety under the mentorship of industry luminaries. The chapter not only sheds light on overcoming challenges and celebrating triumphs but also on the diverse cultural insights gained from working with global teams.

As the healthcare landscape evolves, so do the tools and technologies shaping its future. Rishi lends his global perspective on the burgeoning role of artificial intelligence and the potential of social media in revolutionizing patient data collection. The conversation turns to the frontiers of personalized medicine and the anticipation of new roles that will merge technology with patient care. Our episode culminates with an eye on harmonizing global regulations, ensuring that, through collaboration and innovation, patient safety remains at the heart of pharmacovigilance. Join us for a riveting dialogue that promises to leave you enlightened and excited about the future of healthcare.

Speaker 1

Welcome to another episode of Innovation and the Future of Pharmacovigilance, a podcast series brought to you by Trulient Talks. I'm your host, indi Alawalia, and I'm delighted to navigate the dynamic world of pharmacovigilance and risk management with you. A quick disclaimer first the opinions expressed in this episode are solely those of the individual guest and do not necessarily reflect the official views of Trulient Consulting or their own company. We're all about fostering insightful conversations here at Trulient 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. So today we are incredibly fortunate to have Rishi Chopra, executive Director, global Head of Pharmacovigilance Regions and also Deputy UK QPPV, as our guest speaker. Rishi, it's fantastic to have you here.

Speaker 2

Hi Indi. Thank you so much. Yeah, thanks for the invitation and, yeah, this opportunity to speak to you. We've known each other for quite a bit. I feel like I'm talking to a friend, so I appreciate it. Yeah.

Speaker 1

Yeah, you have been pretty much my whole PV career. I think I've pretty much seen you everywhere, every conference, every. I think he even did an interview once. So, yeah, I think the first thing that I want to ask is how did you get into PV?

Speaker 2

Yeah, good question. I think with a lot of folks that enter pharmacovigilance it's probably not the case that when they were asked when they were a five-year-old what they want to be when they grow up, the answer was probably wasn't PV professional. But really, look, I did an undergraduate course in biochemistry and coming out of that bachelor's I still didn't really understand what I wanted to do. I think all I really knew that I didn't really want to stay in the labs. I didn't think that was for me. I think by nature I get my energy from people, so whatever I wanted to do in the future had to be centered around collaborating with folks. So that much I knew, but not specifically. And so then I went on to kind of prolong my educational experience and maybe some time in the student union bar by doing another course in.

Speaker 2

It was a master's in pharmaceutical science and business management, and that was a really interesting course because it was at Kingston University and it was a hybrid course. So the pharmaceutical science piece is everything that you would expect is understanding each component of the pharmaceutical industry, and within that there was a module of pharmacovigilance. But the other half was the first time that they had offered. It was an opportunity to do some business management modules with the business management cohort of students and I was the first from the life science side to do that. So it was just me from the life science cohort understanding and taking part in some of the modules with the pure business management students. So that was really interesting the first time I had been exposed to anything from from that perspective and it really taught me about not only the scientific side but it also taught me about how companies operate, which was a good insight.

Speaker 2

But, like I said, there was a PV module in there and after that really I had a cousin that was working in regulatory affairs within the industry. She had been working in the industry for several years. So really that was the first point of inspiration. I started thinking about the pharmaceutical industry post masters and I was very lucky enough to really get my first job in PV almost immediately after I finished my masters at Kingston. So, yeah, that's really the story. And no, I don't, I wouldn't say it was a. It was a carefully structured plan and strategy to get into PV. But I mean, I truly mean this. I was lucky enough to fall into PV and then from there on kind of build a career in it.

Speaker 1

And that first role was that rush. Is that right? Yeah, it was that rush. Yeah, that's right, yeah. And how was that experience for you to you know newly, newly graduated out of Kingston and straight into Ross.

Speaker 2

Yeah, I think it was actually very lucky for me to get my first job in industry and in farm convictions at a company like Russia, a fantastic organization, and, like I said, I get get my energy from people.

Speaker 2

And I think the most striking thing about my time at rush as, if you like, the first real job, right Apart from working in retail during university was was the fact that I was joining a real community of folks in a global farm convictions department and really the environment was all about sharing, partnering, learning, and so it was a.

Speaker 2

It was an excellent entry for me into the industry and and really learn for some. I mean not only great managers, but just have fantastic colleagues around us. And I think maybe show in the age, but it was back in the day we, you know, get into case processing as your entry level role, for example, and we did everything, have the opportunity to try everything, whether it was processing different cases, whether it was learning about training, processing, process management, outsourced in strategy. I mean it was a great environment for someone that was really eager to learn farm convictions at a foundational level. So it gave me a fantastic foundation from there. So I think rush was a fantastic experience, and I say very lucky because kept connections, really strong connections, ever since then and I've been very proud to see the trajectory of my colleagues from those days. So so yeah, fantastic experience.

Speaker 1

And that early on did you know where you wanted to go in your PV journey, or was it just? Well, I'm processing cases, I'm learning a bit of the safety side stuff. I think signalling might be just with signaling around, just sort of in its infancies, or sort of very basic signaling At that point, I mean I had exposure to that side at a very, very foundational level, you know, not in too much detail.

Speaker 2

To answer your question did I really know where I wanted to go from there? The answer is no, not really All I knew at that point. It was only the first two or three years of my career. Right was and really getting to understand farm convictions and I have to be honest, at that point you don't really, or I did not, have a really intimate understanding about the importance of patient safety and farm convictions. Right, you get the foundational training which tells you about the lidomide disaster, etc. The foundations and the roots of farm convictions as we know it today. But it really didn't, if I can say, hit home yet at that point.

Speaker 2

And so what I did know is that I wanted to further my journey and education in farm convictions, if you like, by taking up another opportunity at GlaxoSmith Climb which really took me from a global function into a local function. So I took a role within the local safety team in GSK's UK affiliate, which again was a real fantastic experience. So, to answer your question, I don't really know Again, did I especially target that next move? No, there was an opportunity that came up and it really struck me that this offers a different insight from a different perspective, from a local perspective, a little bit closer to the needs of the local business as well as the local patient population, and also a different therapeutic portfolio, which was interesting, very diverse portfolio at GlaxoSmith Climb, including vaccines and HIV portfolio on top of the respiratory oncology. So that really was an attraction for me to take up the role at GSK and have a new experience.

Career Growth and Industry Collaboration

Speaker 1

I mean that's it's quite fun, it's quite, it's quite incredible. You had this. Your early part of your career was literally. You had the global Outlook as your first In sort of introduction into PV, and then you went down to the local level. Was it at this point that you started to get more involved with industry associations, or was that a bit later on?

Speaker 2

Yeah, it was. No, it was a black. So Smith Klein, so you're taking me back. Indeed, I have to remember now it was at black. So, smith Klein, I think what happened at that point is my manager was very involved with both Piper and the AB PI farm provisions expert network and I think there's a couple of times where she gave me the opportunity and and we will come back to it later but I've always had fantastic managers that have offered me opportunity and allowed me to grow, which is really important, which gave me that opportunity to take part of a lot of trust there, because representation of the company and and providing valuable input into some of these trade associations really important, so Fantastic amount of trust that was placed in me. But it was a great opportunity to again, I think it was the first time I got the opportunity to work on something with, with colleagues from other companies and other parts of the industry. So, yeah, I think it was Piper and a BPI Farm provisions expert network that started to interact with during my time at GSK.

Speaker 1

Yeah, Was that surprising to you that industry did collaborate in that way? I?

Speaker 2

Think a question was it surprising to me?

Speaker 2

I don't think it was actually.

Speaker 2

I don't think it was particularly surprising to me, but for me personally it was.

Speaker 2

It was something brand new to see how Trade associations and industry associations can have a really important influence and contribution to our overall a Farmer Covenants framework. Right, and and I think I mean in other ways GSK had really given me the Appreciation, started to give me the true appreciation of the impact of the work that we do within patient safety and farm covenants, you know to to the population in terms of health and well-being. But from a trade association perspective, we started to work on some papers that influenced the way that we do things and it was all in the ultimate interest of of patient safety and compliance, and so that started to give me a deeper appreciation of the value of colleagues across the industry and trade associations In in having a positive influence around how we can kind of progress things, you know, in the name of the patient. So, yeah, it wasn't surprising me that they were interacting, but the the impacts, the positive impact was, was definitely something. That was the something new to me and it was a great exposure.

Speaker 1

Yeah, and I think that's the first time that I I had actually heard your name which was the I think it was the ABPI guidance for digital media and PV. Yeah, yeah, yeah, it was good, but I mean, it's quite interesting that you know where we, 10 years later, 11 years later, it's still V. It's still V guidance that people still look to, which is a Maybe slightly a sad indictment of how we haven't moved on as an industry, or we don't move quick enough, or it's the fact that it's it's lasted its time and I that might have sounded a bit offensive, but I didn't need it to sound offensive, it's just I guess it's the way it is and and I believe At that point you were about to move to Janssen, is that right?

Speaker 2

Yeah, I mean, I mean on the paper that that had been developed subsequent to that Um, several times, even by some of my team members that were companies that I joined later on, um, and I think it was just. It's just testament to the fact that that area is is complex, right, um, quite rightfully, there is a lot more red tape and and and and and, uh, um, the framework around how pharma and biotech operates in the public space, including social Social media. Quite rightly so, we're dealing with not to underplay it, but life and death. Sometimes we're dealing with people's health, which is a really, really important topic, and so, um, it's not so easy, because technology moves incredibly fast, right, and All of social and digital has moved incredibly fast. Platforms and the use of the platforms that have moved and developed even more so. So, um, it's it's difficult to kind of tie down, uh, guidance and framework which will ever last that pace of change, right? So I think the industry and companies have to keep thinking, keep talking, keep being pragmatic in terms of how they operate, and just keep patient safety and compliance at the core of what they do, and then they'll stare themselves in the right direction, I'm sure, um.

Speaker 2

But yeah, you're going back to the other question around my move from there on and it really was our point where, again, because of the, the trust and the faith that that my manager had with me that time, she gave me more opportunities to to to, to kind of take on supervisory roles at times and also backup roles for her when she was, uh, not there. Um, and that gave me a flavor of what it was like to to to, I guess, first lead a team or to actually Uh, coordinate a team, supervise a team, and that's what I wanted to do. Next, I really wanted to manage a team and that's where the opportunity at Janssen came along and, um, it was, uh, again, really fantastic experience, fantastic um company and Learn a huge amount and then through uh, some really dynamic and testing times, quite rightly like inspections, etc. But really positive experiences and outcomes from them and, once again, you know, really add the opportunity to make some firm friends and and uh, ever since that I've kind of maintained contact with ever since and Uh, yeah, so so went to Janssen to take up a role in in managing Uh a team within pharma convergence operations, uh, and it was a uk-based team that eventually was also joined with, I had to to manage a us-based team as well. So, again, a fantastic experience.

Speaker 2

And I think during that time I first started to interact more closely with the functions, like the e, u, qppv, other pv operations, roles, the affiliates, um, and I think, um, it was then around about 2012, right when the gvp modules first came out, and then the experience of of leading and coordinating the implementation of gvp module six, which is, I guess, for pv, has been a significant milestone event, right, and and uh, those modules are still around and being updated, so so it was a. It was a significant milestone and experience for me, um, but yeah, so that was a fantastic move from me here and Also around that time you were also doing a white paper, uh, for.

Speaker 2

Yeah, toughs, yeah, so this was something that um, during that time there was again an industry-wide Um initiative with toughs led by Tufts University to start looking at again in the area of social media. So it was just a um. I guess my it's really sparked my interest during my time at gsk around Digital and social and how that was being used. And I have to say in those early years, um, it was still a lot of Ambiguity about the value of the data that was on social and digital media right and With complexities like the risk of duplication and noise and false reports. So it was really just an opportunity to To further my experience in talking with colleagues across the industry and varying different experiences. Um, so yeah, so that was another opportunity to be exposed to to that area.

Speaker 1

So you're at Janssen, you've, you've probably grown into a, into being a leader at this point. You've, you've, you've got your experiences from the past. You've, you've been able to be part of this, this whole GVP module roll out, which I think that was pretty early on in my career and it was huge. I was at a small company at the time, so I can only imagine for someone like yansen it was. It was a big big deal. And then what made you decide okay, now's the time To move on.

Speaker 2

Yeah, I mean, did I really? I don't know if I really started my journey in terms of being a, a full blown leader at that point in yansen. Certainly it was my first experience of managing people, but you know there's Different team just managing people and being a leader. In fact, you might be, you don't have to manage people to be a leader, right? So different, slightly different concepts, but sometimes into time as well, certainly that experience of managing people is great and looking after as really good managers had looked after me in terms of my own development and opportunity, trying to practice what I learned from those managers and look after the development and opportunity of others. So that was that was fantastic experience.

Speaker 2

And yeah, like you said, implementing GVP module six was was a great experience and it was Daunting at the beginning because it is a large organization and it was complex yet the farmer and the consumer portfolio and it was implementation across both sides of that business. But that's when I say that, that that's when I started to get exposed more and more to the affiliates, talking and partnering with the safety officers, understanding how their countries were implementing the EU guidelines at a local legislative level, local guidance level, and interacting and understanding and appreciating that there are different flavors of interpretation country to country. And that was fascinating to me really was, and I guess I wanted to build on that experience of an opportunity to kind of interact with the different affiliates in different countries. And so an opportunity came up to cater and where I would be a regional lead, I guess, the I S region of affiliates. So I took that kind of next step of my journey.

Speaker 2

You know, so is it was, if you like, I went from a global office Into a regional center or a regional capacity, but still as a representative of the global office at Takeda, global PV At Takeda. So so, yeah, that was the. That was the reason why I wanted to move into that role really is to is to really get more experience and more exposure of interacting more closely with the affiliates and not only the PV folks Within the countries but also the broader business. So yeah, so that's what, what took me there, and then from then you went to Otsuka yeah, yeah, I'll see her.

Speaker 2

Yeah, previous manager and referred me to an opportunity at Otsuka which was to kind of Leave the compliance framework there, especially in the run up to an important inspection, and it was really looking at the compliance with module two, what should be in the farm division system master files, supporting the setup of a compliance management framework, continuing to work really closely with the EUP, pv and the folks in the PVP, the office as well as Other folks within PV operations and Cap management. So, yeah, great, great experience and that Otsuka, again very good experience. And that Otsuka, again very lucky to join a fantastic company with with Fantastic heritage and a beautiful organizational culture, and it was great again to interact with folks, but from a different lens, you know there, compared to my previous experiences and yeah, it was, it was just good to kind of get that, to try my hand at a different part of the farm provisions work or oversight framework, you know.

Speaker 1

And then the thing that surprised me, because I didn't realize you were there for so long with Biogen. I didn't realize you were there for well over six years.

Speaker 2

Yeah, it was about I think it was coming up to six years. I think I really decided that point, that I really wanted to go back to working with the affiliate sector.

Speaker 2

I really enjoyed it at Takeda. I really enjoyed being part of the affiliate at GSK and again, I had the interactions with the affiliate community within both Janssen and at Altsuka, still within compliance. I just wanted to go back to that. The role was really attractive, actually even more so. The people that had interviewed me really gave me the motivation to join that organization. It felt like things were still building. It felt like it was a tremendous opportunity to build a true farm convergence community with the affiliate sector. I would be working not just within one region but leading all regions of affiliates across the globe.

Speaker 2

It was an expansion. It was the next logical expansion to what I was doing at Takeda and it was also the opportunity to first time join the global PV leadership team. Again, I guess it was the next step in my overall development and learning was then to start practicing providing a contribution to farm convergence leadership beyond my immediate remit. Yes, I'm coming from the perspective of I lead the affiliate network function, but it was beyond that. How do you provide a contribution to the betterment of the farm convergence system alongside my colleagues that are on the PV leadership team? So that was again an experience as well.

Speaker 1

And at this point at Biogen. This is when you again were heavily involved with some of the industry.

Speaker 2

Yeah, some of the associations except there we go At this point.

Speaker 1

Yeah, so you were some industry associations, you were doing some lecturing, like there was a whole load of things happening for you at that point, right?

Speaker 2

Yeah, I mean in phases. So for a long time it was really about establishing myself as well as my ideas on creating a really useful, a really unified farm convergence system that was inclusive of all of the affiliates around the world, right, Because I think prior there had been a level of decentralization of how farm convergence had functioned within the affiliate sector, so it was to kind of harmonize that over the few years. So really it was focused on that for the first few years and then maybe, as I kind of got more comfortable and established in the role and I think that's important for anybody considering the extra curricular stuff, it's really nice but you have to pay focus to the core role, right. And so that was my focus for a few years. And then, I don't know, it just felt like it was again, it was just by chance interaction with a lecturer of one of my previous universities at Kingston, and then also I would get the alumni newsletters from Westminster, and so then there was reach out from those universities to see whether there was any chance of me doing some lectures.

Speaker 2

I thought that would be quite useful because I think when I did, I mean there's been other great courses, like the PV course at Hertfordshire University which I did a diploma in, and so they offer great teachings in from Covisions by thought. In some of the other courses at certainly the universities that I have been in, it would be great to get direct experience or for the students have, you know, interaction with someone from the industry to give the, and so that's what I did. So at University of Kingston I gave kind of like an industry perspective and then from for University of Westminster, I was interacting with them around the importance of mentorship and leadership and they also had a series called what it Takes. So it's all the students to kind of get different insights from different industries as to what it takes to become a leader or what it takes to you know various different topics. So so, yeah, so that's when I started to kind of practice lecturing to students, which is a different experience, you know.

Speaker 1

And and finally you. You've ended up now where you are at CSL.

Speaker 2

Yeah.

Speaker 1

And how. And actually, if I look at your whole career, I sometimes I ask people about how they feel about working with companies from you know that have got different cultures. So you know we have the Japanese culture, the Swiss culture, the UK culture, etc. You've actually managed to pretty much hit everything, every single one of those sort of companies.

Speaker 2

I wasn't following a checkbox or companies and cultures that I wanted to cover. Quite sincerely, I think there's a couple of things that have influenced my decision to explore new opportunities, which have been about people and it's been about the role. And in those two aspects, it was just a compelling, really compelling situation with which led me to join CSL, a fantastic organization. People are passionate really about this topic of patient safety and there is such great opportunity to put your mark on things and really influence and drive forward. And look, I'm still learning from great leaders, and that hasn't changed today, you know, and that has been the real stimulating factor is can I continue my learning journey and can I keep doing the things that I'm particularly passionate about, which is patient safety?

Speaker 2

And, like I said at the beginning, did I really have an appreciation of the contribution that pharmacovigents functions make to patient safety?

Speaker 2

I didn't, not in those early years, for sure not. But, you know, throughout my career I've had the opportunity to talk directly to patients and healthcare professionals. I understand what it means to them to take and have access to potentially life changing therapies Right, and I've seen the important work that we do right across all functions of pharmacovigents in that mission and I've also seen the variety through the different countries in terms of what it means to provide more tailored or specific or nuanced service to patient safety, and so I really wanted to continue my journey in the affiliate sector and again, it's the opportunity was the role that CSL, but really importantly, it was the leadership. It was the people that really have kind of brought me here and, look, you know, I've been blessed in that way and continue my journey in that way and I've got fantastic colleagues around me. This is a really fantastic step for me. So that's why I'm here at CSL and it's already been almost two years since I've been here.

Speaker 1

So, yeah, it's going really well and you talk about a lot about the, the leaders that you've had throughout your career and how influential they are. What is it about those, those particular leaders that helped you throughout your career that you, I guess, are you grateful for, or what is it that made them stand out to you and made you want to pursue yourself and your learnings going forward?

Future of PV Leadership Technology

Speaker 2

Yeah, it's a really good question. So I think, on reflection, the reason why I say I've been lucky with the managers and the leaders that I've been exposed to is because I found that those Manifest if we start with the managers, my direct managers they I've always had the opportunity to try something new and Sometimes make measured mistakes. You know and learn from them quickly, and so that's something that kind of hold dear in the way that I try to manage people is to give opportunity, allow them to Expand the breadth of what they currently know and and do and try something different, because I think out of that kind of you you can breed more innovation and also personal development for the individual. But then a lot of those leaders are not only the managers but the leaders that have been exposed to have kind of Led by example, right, and I've particularly been blessed with being surrounded by Leaders with individuality. Right, they say there's something about them that separates them or differentiates them from the next leader, and every different style has something to offer, in my belief.

Speaker 2

Right, and I Would also say I've been been blessed to have authentic leaders. So, and I think, I think that's a lot a lot of people talk about authenticity as a leadership behavior, but it's really, really important to be an authentic leader. In my view, and that's what I've tried to emulate, the best that I can is just to be myself in terms of my personality, be humble about what I know, what I don't know, and Also allow people to be themselves, to be comfortable in their skin and and Be as inclusive as possible. So, yes, I think that I think those are the leaders that I've really appreciated and, again, I've been very blessed to have to help me develop my own career.

Speaker 1

And and and you have a very big sense of paying it back as well. It comes through a lot that you want to be able to pay back what people have have given the opportunities to yourself, and the one thing that I that I think about is, in the world of PV that we're in right now, how Do leaders pay back to the? The newer generation of PV leaders are potentially coming through.

Speaker 2

It's a good question. I mean, look, I'm still learning, right, so there is, there is, there is that? So I think it's first understanding is that my way isn't, it's not the, the way it's not the right is not necessarily correct in all fashions, but but it's the way that suits me, that I do it with really positive intent and I think that's the key thing is to to to make sure that we kind of Give our folks the space to, to to positively contribute to whatever they do and understand whatever contribution that they make. We should assume positive intentions and and some people may think it's classed as paying back but I actually get something out of it myself. So it's not completely Selfless, right, it's it.

Speaker 2

I get something out, I get, I feel, like a reward if I'm kind of, you know, going to some of these lectures, and I don't do it very often.

Speaker 2

I might do it like once every Year or it's a couple of years, but whenever I do get the opportunity to do it, I do feel like there is something that I get back out of it in terms of just sharing an experience, and I think it's valuable, because when you're in, maybe we all know this one, when we're in University. I mean, what do we know about operating in a corporate environment and and some of the finer details of operating it Matrix environments, etc. We don't. And I think sharing that perspective from an early stage More to do with the soft skills etc Is just as important as the technical knowledge that they'll learn from their courses, right? So so I do think there is a value with with folks from industry providing perspective Back to the students that are still learning and and and, but, like, like I say, it was not, it's not, it's paying it back, maybe a little bit, but but it's also. I get something out of that, you know, you know.

Speaker 1

Is there any leader that you can think of that you would name, check this instant and say this person's view is Something that I, or this person's way of being a leader, is something I aspire to? I?

Speaker 2

Think, look like I say I've been blessed to have really good managers and leaders Around me throughout throughout my career really good, you know. I've learned from all of them and I continue learning today. I'm very blessed today to have the leaders that I have and the managers that I have today and learning from them. I think it more so than name-checking, I think it's about the profile of a leader that I've really appreciated. Again, going back to the things that I talked about, real authentic leaders, leaders that are really comfortable in who they are and and I find it just Brilliant that that people can be who they are and offer something different and really big believer in diversity of contribution, right and inclusivity and you know for me that that's why I've invested is those those leaders that are really comfortable with their brand of leadership and are an authentic, and that's what I've always tried to aspire to, to be myself, yeah.

Speaker 1

I think that's. That's fair. So the name of the podcast is innovation and the future of farming convenience. So we have to ask this question what? What is next for PV? What's the next thing?

Tech and Patients in Healthcare

Speaker 2

Yeah, I think probably the the obvious one that you know We've been talking about for the last couple of years at least in industry is is the oven of technology and the progress that that will. That will make an enhance in terms of our procedures and the way that we do things. So, specifically, ai, generative AI and LP, etc. I think all of that will will definitely contribute. I think that's a given that that will play a massive role and for some companies that are further along Than others and you know it's already playing a role for them in some way. So I think that's that's really important and it will probably free up the capacity to look at more value add and I think he I mean and that a lot of the conversation around that is on the back end of how do we use AI for data management. You know we've in regulation with progressively we're asking to collect more and report more, and I think AI has a support opportunity for that. On the other side, I think it'll be interesting how the rest of the organization or the industry utilizes technology and taps into into sources or potential new sources of data or or under used sources of data. So it's always been a concept in farm convictions that there is severe under reporting of AEs. A lot of the times when people report adverse events, are they reporting it purely for the sake of reporting an adverse event? Well, quite frequently they're reporting because they're mentioning it in the context of something else that they want out of it, whether it's medical information or to share a story or to get other people's experiences. And I wonder whether, again, we talk about the social and digital media. At the beginning, there's always people dubious about, well, what kind of quality of data is really out there. But I wonder whether those same data sources will become richer in the future. Mainly because of our number one, patients are becoming more learned about their conditions and their treatments and the disease and they want more of an active contribution in that journey. So are they now also building stronger communities with their, with other patients of the same area and talking about their therapy and their treatments more and their experiences? And I wonder whether some of that data is becoming richer out there and again is yet to be untapped.

Speaker 2

The technology, just as much as it has a role in supporting the back end of data management, it also has a role in, perhaps in a more efficient way helping us to tap into those new data sources. So it's yet to be discovered, but I think that's the future is to how do we leverage technology more and more, both from the aspect of data management, but also to maybe explore if there are new data sets out there that provide a richer and more fuller insight into the patient or experience, right? So I think that's one thing. I think the other thing is that that is also aligned to this concept is I also think that medicine is moving towards more personalized experiences. So in previous companies I've seen the value that medical devices and digital has on the overall patient experience.

Speaker 2

So again, I wonder whether the patient will become more of a collaborator in the generation of their own data and the assessment of their data. And so I wonder the role of if there's going to be a much stronger role for the patient within industries. We talk about patient centricity. Maybe there's going to be a chief patient officer in a lot of companies in the future. So again, I think, as healthcare develops, the technology develops around it and the patient becomes more learned about their own treatment and disease outcomes and once more of an impersonal investment in that journey other than just looking to their healthcare professional for advice. I think the data will become richer and will probably have a better outcomes and assessment and outcomes on the back of it.

Speaker 1

That's fascinating. That's a really good point, and actually there's one other thing that came up which we haven't really touched upon, but it's a big conversation at the moment about the convergence or the divergence of regulators and the way that they're looking at regulating our industry. You're getting some of the maybe not so traditional regulators coming up with some regulations which are innovative, as it were, compared to maybe the bigger ones, who are slightly slower to come to some sort of consensus to be able to regulate the industry, and your role has obviously, is global in that respect, and you see all this. Do you see any big changes or foresee any big changes in that in the future?

Speaker 2

Yeah.

Speaker 2

I think trade associations and many of the well-established regulators are putting in a lot of commitment to kind of work and collaborate with each other, with some of the burgeoning regulators out there, so that as much as possible, we can harmonize and share experiences.

Speaker 2

So I think in a lot of the burgeoning regulators we'll see them advance as well, and I guess that's also why my job I feel my job is particularly interesting, because we're at the front end of being exposed to that.

Speaker 2

All of those varied requirements country to country, yeah, belief that all of these, the regulators ultimately we all want to do the same thing, which is to really make sure that the patients are served and that we have their safety. Call everything what we do. So I do think that there will be more continuing efforts by trade associations as well as regulators to share experiences and opportunities to harmonize so we can expect more and more of that collaboration to happen. So there's been the work that the Bill, the Millindigates Foundation, has been doing. The MHA has been really active outside of EU as well, and we know that many trade associations out there are interacting very well with a lot of the regulators to share experiences and influence wherever they can. So I do think that we'll continue to see variation in requirements country to country, and in some cases rightfully so. They have different patient demographics and different needs, so we shouldn't necessarily expect to see exactly the same requirements everywhere. But I think there will be a continuing effort globally to harmonize wherever possible.

Speaker 1

Rishi, thank you very much for joining me on this podcast. It's been an absolute pleasure talking to you.

Speaker 2

Yeah, thank you, indy. Thanks, Good chatting with you again and yeah, we'll go for a beer sometime.

Speaker 1

Absolutely Thanks, take care Bye.