Optimising regulation and ethics in research | ACRN Podcast EP08

Optimising Regulation and Ethics in Clinical Research: Building Faster, Smarter Trial Systems in Africa

What happens before the first participant is ever enrolled in a clinical trial? Behind every breakthrough treatment lies months of regulatory reviews, ethics approvals, contracts, site preparation, and countless behind-the-scenes processes that determine how quickly new medicines reach the people who need them.

In this episode of the ACRN Health Podcast, host Wilfred Gurupira is joined by Dr. Tariro Makadzange, CEO of the Africa Clinical Research Network (ACRN), and Knowledge Ushamba, ACRN's Regulatory Affairs Officer, to unpack the often-overlooked world of clinical trial startup.

Together, they discuss why Africa conducts only a small fraction of the world's clinical trials despite carrying a significant share of the global disease burden, and explore practical solutions to make research more efficient, predictable, and globally competitive.

In this episode, you'll learn:

•  What happens between developing a research protocol and enrolling the first participant. 
•  Why ethics and regulatory approvals are essential—and why they often take longer than necessary. 
•  The challenges of navigating different regulatory systems across African countries. 
•  Lessons from the COVID-19 pandemic on accelerating clinical trial approvals without compromising safety. 
•  How regulatory harmonisation initiatives, including the African Medicines Agency (AMA), could transform research across the continent. 
•  Why parallel reviews, common application systems, and stronger collaboration can dramatically reduce trial startup times. 
•  How improving research systems benefits patients by bringing innovative treatments to communities sooner. 

Whether you're a researcher, policymaker, healthcare professional, student, or simply curious about how new medicines are developed, this conversation offers valuable insight into the systems that shape the future of healthcare innovation in Africa.

🎧 Listen now and discover how stronger regulatory systems can help Africa lead the next generation of clinical research.

Transcript

SPEAKER_00 0:19

Hello, everyone, welcome again to another episode of the Acer and Health Podcast. I'm your host, Wilfred Gurupira. And today we want to go behind the scenes a little bit about what actually happens in a clinical trial. And to help me unpack this black box, I'm joined once again by uh our CEO, uh Dr. Taru Makazange. And joining us for the first time is Mr. Knowledge Usamba, who is our regulator affairs officer. Welcome, Dr. Taru. Welcome, Knowledge.

SPEAKER_01 0:55

Thank you, Wilfred.

SPEAKER_02 0:57

It's nice to be with you.

SPEAKER_00 1:01

So I wanted to talk a little bit about what happens in the background. We talk a lot about the science, the breakthroughs, the results of clinical trials. And Dr. Tarot, most people don't know what's happening behind the scenes, you know, that period before the first person walks in in the doors. Take us through that period. What is actually happening?

SPEAKER_02 1:30

Great, thanks. Thanks, Wilfred. And I think it's an important question because most people, and to be honest, myself included, until many, many years into being a physician, really didn't understand what goes into doing clinical trials. So, you know, the science being ready and the trial being ready to start are two very different things. A trial can be fully funded, fully staffed, nurses uh trained, freezers running, your generators working, you're ready to go. And you may still be many, many months before uh you're ready to enroll the first participant. And so the question is, what's happening uh during that period? And typically, in that period, uh things like ethics review are taking place, so independent committees uh that look at the research and confirm whether it's safe and ethical to do, a national regulatory authority. Um, so each country has a medicines authority or medicines agency that reviews any trial that could involve uh any uh therapeutic uh agents. There may be institutional agreements, contracts between sites and institutions and investigators, a hospital or research uh site. There may be import permits, uh, so things that you often don't think about that can be significant barriers, uh particularly for any investigational product, laboratory reagents, there's delegation logs, lab pharmacy qualifications, etc. So a lot of things are happening behind the the uh the scenes. And uh none of these things are pointless, actually. They're all very important uh for enabling research. And every one of them exists um because, as I like to say to our team, our business is a data quality business. We want to generate data that people all over the world can trust, can use. Uh, the drugs, when they approved, may be given to tens of millions, if not billions, of uh individuals. Um so all of these are important and they exist because in clinical research, there's been a history of things going wrong uh when uh that oversight is absent. Um so the problem is not that they exist, uh, the problem is that um if they're done sequentially or in isolation uh or not very well planned uh without sort of clear clocks and timelines, it can become a barrier rather than an enabler for um access to medicines.

SPEAKER_00 4:18

Okay. So so I want to ask you, Knowledge. Um you sit in this process every day. When a new study arrives at a site or within the ACR, for example, what's the first thing you're looking at?

SPEAKER_01 4:32

So thank you very much, Wilfred. So before I even read the protocol, uh I look at the map. Which country is this study uh going to be conducted? Because the moment you look, you know the countries where this study is going to be conducted, you now know the terrain. Because um the terrain is never the same in each and every uh country, it's never even formed. Each and every country is its own uh systems and so forth. Uh, there is no single African regulatory system. We do have around 54 African countries in uh in Africa, and what MCA is that uh here in Zimbabwe asked for is actually not the same as uh NAFDAC in Nigeria asked for. It's also not the same as SAPRA in South Africa asked for. So there are different forms, different formas, different fees, different community calendars, uh different um and language submissions, so to say. So for a multi-country uh study, going to three African different countries, um, I'll take that as three projects that are wearing one jacket.

SPEAKER_00 5:47

Thank you so much for that response knowledge. It it kind of makes me wonder what Dr. Tara is thinking, going into 54 countries with all these different processes. But Dr. Sarub, um, coming back to you, there's data that uh COVID trials in Kenya were activated in a very short time, 80 days, whilst non-COVID trials were at the same institution took 260 days, almost three times the the time. So it's the same country, same institutions, same regulatory system. You know, knowledge was talking about the 54 different countries, but here we're talking about just one country, Kenya. So, what does that gap tell you?

SPEAKER_02 6:33

Yeah, I I think just to start by saying, I guess they're 54 of us, uh, but as I always like to say, we really should be one. Uh and I think this is a space where that oneness might be easier to pull all together. Uh, because you know, I think we could all agree uh that all regulators want to make sure that only safe, uh efficacious drugs are introduced into their um uh markets. Uh, all regulators want to comply with international uh standards for doing uh research. So I actually think that there's a lot of good common ground here that can form the basis of everybody uh working synergistically so that we we all want, you know, like India or China, right? You know, 55 were one entity. And I love the the example that you give, and it wasn't only Kenya, it was uh quite a few places globally that said, hey, wait a minute, we have a global emergency here. What is it that, you know, if I'm the FDA makes it take so long to get a trial from initiation uh to activation? So you know, that time to trial uh activation. What is it as MCA, Z, Zapper, etc.? So a lot of uh regulatory agencies really thought about this, and and COVID uh became an uh opportunity for for folks to streamline that. Um and so the data really tells you that the bottleneck is not really about capacity, it's more about organization and systems. Um people still uh provided the same quality of oversight, etc. But what are our operating systems so that we can be continuously efficient? So everyone knows that we have a clock, right? We have a pendant to put people back to work. It'd be nice if we felt we had a clock with everything, right? We uh, you know, whether you're dealing with a drug for diabetes or a drug for oncology, the patients down the line that want to access that medication as urgently as possible. So if we had the same urgency for preeclampsia, for HIV, for malaria, for TB, uh, etc., then you start to think on the systems uh uh uh level. So, you know, how do we do things in parallel? Uh how can ethics committee come together and and review things um uh together? Uh, how can we move contracts much more uh efficiently up? So I think there's a lot of learnings from that time, which you know, fortunately as humans, we forget things very quickly. So I debate we should be saying why isn't everything 80 days rather than the status thing suppose. So it's doable, it's a systems issue and and um uh a um policy systems and and agencies working more efficiently and effectively together.

SPEAKER_00 9:54

Wonderful. No, I I I get your point about how quickly you forget. You remember uh uh during COVID would it would all be masked up right now speaking? Those are yeah, what a time. But knowledge, I I want to turn to you and you know, from the regulatory side, find out what are some of the more common reasons that startup takes longer than it should. And I want you to be very honest with us. Don't don't kind of give us the the the nice answers, just try and be honest. Why does it take so long?

SPEAKER_01 10:28

Uh thank you very much, Wilfred. Uh, I'll try to be as honest as possible as I can. Um, so the honest answer, I think it might be very uncomfortable, but the fold is actually not distributed. There is a non-narrative, especially in international circles, finding African regulators and saying, Oh, well, you are the bottleneck, uh pointing the finger in regulators, saying you are the one who is causing uh the bottleneck. Well, it is a convenient story, but how but however it's also incomplete. So, in my experience, a regulator officer, like I hear it is here, and um I'll name uh at least uh three primary reasons. First, I think it sits with the with the sponsor. I mean the sponsor actually providing an incomplete dossier. Um, I'll give you an example uh a dossier that is tailored uh for an FDA or for an European uh medicines agent submission, but however, it doesn't suit our African um context. This is this this is a global trap, uh but however, you're creating a dossier that is fit for the FDA, uh, for the European Medicines uh uh authority, but it doesn't, however, suit our African so that that is point number one. Um the claim also is well lied with this force. I'll move on to then um the second point the sites themselves. And sites are in uh some of our African sites, are they even ready? Uh a site can uh do they have like appropriate SOPs? Do they have like a documentation like in place? Do you do you have like your GCP certificates, your CDs, your accreditation uh place? So these are some of the things that can actually delay trial activation. Then the third point which I would like to uh to make uh is on the jurisdictions and ethics review uh and approvals in hand, there's no like shades uh submission portals. Normally uh, mission uh some of our submissions are actually sequential uh rather than like a parallel submission, one ethics body reviewing the same protocol, the next are getting the uh ethics body reviewing the same protocol, even up to the regulator reviewing uh like a sample protocol. So it's actually sequential and one process starts from uh from um from one ethics body to another in a sequential manner. It's actually also delaying like a trial activation. So those are the three main um uh points or reasons um which I've seen with laying a trial activation and so yeah, yeah, it's spoken like a true regulatory person.

SPEAKER_00 13:33

You try to balance it. Oh I'll come back to you, Nolish, but I want to turn to to you, uh Dr. Talira. In our discussions, we've uh thrown around this figure of how much clinical trial work is actually done on the continent. And there's a figure that in 2023 Africa hosted um around 1% of global clinical trials, despite having a quarter of the burden. Now, I want to get your thoughts on when you hear that number. How does it make you feel? And yeah, what what can you just say about that when you when you hear those figures?

SPEAKER_02 14:20

I think it's a good question. What does it make it make me feel? It makes me feel the whole reason I wake up every day to work so hard on a it's really our motivation, right? Uh, you know, as Africans strongly feel uh that we shouldn't be 1%, 2%, 3%, depending on how exactly you you measure it. Um and we really should be uh doing research for our medical uh needs uh across the whole spectrum. So for me, it it gives me a sense of frustration, a sense of urgency. Uh that's why we're doing uh what we're uh doing, uh, but also a sense of precision. You know, how how do we do this well? Um so that truly at the core is that data quality business, essentially. And that data quality business sort of encapsulates all that we're talking about. You need to have strong regulatory and ethics oversight to do good research. You need to have strong systems to streamline uh that time, that time to trial uh activation. Uh how do we do that most effectively? You need to have systems uh to enable um uh the project management, clinical operations, all of the operational aspects around clinical trials, all the way through to the data quality, data management, data analytics, uh, etc. So for me personally, it creates that sense of urgency that's really the framework of building ACRN. Uh, but ultimately all of this uh also needs some level of resourcing, right? And so that investment in the science and infrastructure, and only so much of it can come externally. A lot of it has to come internally. And I think as this team uh often hears me say, you know, there's there's no country on the planet that has developed without investing in science and research. Uh so that domestic investment is important, not only on the institutions that deliver the science, the institutions that regulate the science, but and also putting in sound regulatory policies and frameworks that make it cost-effective, easy, quick uh to um get studies uh done on the cons.

SPEAKER_00 16:52

Wow, um I want to take you into maybe the practical uh components of what you've just said. Um this building of the systems, it sounds to me like you know, we want to build a regulatory playbook for for Africa. Uh practically though, Dr. Tadon, um how do we do some of what you're saying from a practical perspective? This the building of a regulatory playbook for for for Africa, so to speak.

SPEAKER_02 17:22

So I think at the moment we we can't build a regulatory playbook, and I think we we should define what that means because we're not a regulator. What we're trying to do is de-risk clinical trials on the continent. And so by this regulatory playbook, we're really thinking about that startup uh period. So I'm a researcher, whether I'm an industry sponsor uh or a collaborating partner, how do I do a trial in Uganda, for example? Uh, from the clinical trial protocol to the uh first patient first visit, what do I need to put in place and how long will it take me to get from that trial protocol to the first patient first visit? As long as our systems remain fragmented, um, as Knowledge was pointing out, we can't have an Africa regulatory playbook. I really hope and wish with enough advocacy will get there. But for now, we'll be uh having a Nigeria regulatory playbook, a Zimbabwe, Uganda, etc. And hopefully, as continental bodies start to develop, we can all say, hey, wait a minute, uh, we're asking for the same things. Uh, can we do this in a much more streamlined, um uh streamlined uh manner? Because ultimately every agency wants the same things, right? They want to know is the person qualified to be a PI? Uh yeah, do you have the the facilities and the knowledge? Are you GCP trained, etc., etc.? It's all the same, whether you're in North Carolina or uh in in uh northern Uganda, it's it's exactly the the same uh same process. But that's what we want to do, and what we mean as ACR and by regulatory label. How can we de-risk trials for sponsors, collaborators by really understanding from the trial protocol or even ideally from the idea, the concept, uh, through to first patient, first visit. What do you claim uh put in place? And let's also work with our regulators to make it predictable so that if I do it this way today, it's gonna be the same tomorrow, it's gonna be the same for the next uh study, uh, etc.

SPEAKER_00 19:44

You know, Dr. Sarah, sometimes I I I I think we should give you a magic wand where you can wave and just bring all these things.

SPEAKER_02 19:51

I wish I had a magic wand.

SPEAKER_00 19:57

All these things just just just come to pass. But I want to turn back to you, Knowledge. Um, I I think we can see you know good signs on the horizon. Um, so for example, the EU has a single submission portal for multi-country trials with Averef that's been working on harmonization for the last 20, almost 30 years now. Now, with the African medicine agency uh being built, I want to get a sense from you. How far away are we from harmonizing regulation on the African continent? And what can sites do in the meantime as we work towards that harmonization?

SPEAKER_01 20:39

Um, I'll start by saying um it is a journey, uh, but however, we are in the right direction, uh so to speak. Um, I'll start like uh by planting uh a flag here first uh because it matters the idea that actually regulators are reviewed together is not actually an European. So Avara which was born um as you pointed out, I think it's about 20 years ago, I think in 2006. Um, out of African regulators, uh jointly reviewing uh a vaccine generally expecting that is uh a face true, a face um uh true side. So the concept is um African evidence, and this is not actually uh theoretical, it actually works. So Avara, so to speak, um as of today, it actually now convenes 55 national authorities and ethics committees. It became the committee of African uh medicines regulatory harmonization initiative that that was in uh 2000 in uh mid 19. It's now it it's it uh it now uh targets uh uh 60 working days, that is 60 working days for this year review times, and then it makes is actually delivered multi-country approvals in 10 to 15 days. So this actually this this module actually and also uh to aid the African medicines uh agents which I think is the the next story uh to that building uh the treaty was which are which which was adopted in in 2019 uh and actually came forth uh 20 uh 2021 uh it has now been signed by 37 member countries and now uh in the 10th uh is exactly the EU logic one high quality submission reaching many regulators uh through one will become the but however i have to be honest about the timeline because force force opting force uh optimism is its own kind of delay full meaningful harmonization is the better part uh uh of a decade away we still have a journey to go uh for full harmonization not in like two years or so but however we are actually in the right direction i would like to to to point that uh i think the reason why um i would give it uh probably like five to ten years i think is um to do initially do with uh bureaucratic uh bureaucracy like in our african settings uh and so forth yeah so you cannot harmonize uh in uh our way especially in some of our bureaucratic uh institutions uh here in africa so two things uh which i would uh like to point out which i think um actually paramount in building like a harmonization here in africa we first of all need to build a country level excellence uh rather than sitting uh one of the interventions uh like as as a country uh individual country needs to to excel rather than just waiting for for us to converge first we want to go fast let's not go alone if you want to go far uh let's go together it's an African so we need both yeah so here at ACR and that means uh real working relationships with the national authorities not just uh transactional uh drop the dossier just pray for leaderships but once where the regulator knows who we are knows our quality standards he knows what to do what to expect um we're not submission lens yeah our end here so so knowledge a couple of things that i want to just uh get into with with what you said we've been doing so average has been around for 20 years you're giving it another 10 years um that's that's that's too long but I wanted to say though yes knowledge um but I'd like to point out that the the direction uh that we are moving towards is actually right the journey might be far here but the direction where we are we are going towards is actually um uh right but i i wanted to say we've got SAPRA in South Africa yes which publishes its meetings and submission dates right and according to the information at hand it has a 10-week target from submission to uh committee recommendation so 10 weeks yeah according to you is that a model that can be replicated in uh other African countries and what do you think it would take uh so uh yes so in fact um uh safra actually proves a point which um uh is actually curved uh over the door of every regulatory authority on this continent you know the deplet uh predictability is merely as variable as it seems we really need to be very predictable um uh in as much as we need to achieve our speed so uh i'll sit in a sponsor's chair for a second in non-10 week cycle yeah in non-10 week cycle um you can you can plan around this periodically fast assistance with the no purpose calendar every time you can build a gun chart around satinity you cannot build one around silence and it's the silence accused the sponsors are i want not the length of the review but the black box no published checklist no target date no one accountable for the worklock sponsors will tolerate a cue but they won't tolerate but but but what they won't tolerate uh is a cue of a non-length uh in a dark home especially when um i'll give you an example uh especially when uh let's say it's five thousand dollars a day uh that is being lost um uh in a day when a site is not being uh activated or if a site is failing to recruit with state of uh a partition um oh that darkness actually is a method that that is uh and we're pointing out to SAPRA so what sapra did was to treat a startup as a measurable operating system published submission that uh dates if you see we say it published committee calendars published fees a target it agrees to be judged against in the market in the market on notice so there is a documented case where uh for one recent global trial uh in South Africa which has actually a trial uh after the United States to get a site up in value uh that is not an accident that is what published accountable timelines so it is predictable so so it is uh predictable it is uh replicable yes but let's be clear on about evidence it takes political will it takes investments in your capacity because the published timeline without stuff like uh to niche it it's just a broken promise with a nicer font and it takes a regulator with the nift to be uh to be out to its own uh the published target okay uh dr sandwich back to you know knowledge of speaking as a sponsor you are a researcher but i i want to i want you not not to answer this question in any wearing any of those ads because i want to get to this question why does the all this matter everything we've discussed about regulatory timelines you talked about the system this is the person who is in Harare or Lagos or Nairobi who one day may be a trial participant or whose relative or child might be in a trial why why does this discussion matter to them?

SPEAKER_02 29:31

Yeah it's it's a great question I think this discussion matters to all of us because it relates to how quickly we can get innovative get access to innovative uh treatments um if the whole process takes years right so some smart person at the University of Lagos uh identifies a chemical compound that can have an impact on disease X but it takes 10 years for that compound to really go through uh the research uh pathway to understand is it safe, is it not safe, does it work, does it not not not work? It means that in that 10-year period people with disease X have not had access uh to the treatment it also means in that 10 year period the scientific community has not learned whether or not treatment Y actually works for treatment X and if we need to pivot to to something else. So it affects all of us it affects our ability to do science and innovation it affects access to treatments for for real real world uh uh patients so so that's those timelines um uh become very important uh you know um on a broad scale uh on an access issue and on a science and innovation uh issue okay no lead I want to go back to you and um you know that magic wand that I wanted to give Dr.

SPEAKER_00 31:02

Tider I'm gonna give it to you but you can only have one wish if you could only change one thing no just one about how clinical trial startup in Africa operates what would that one thing be remember it's just one uh thank you Wilfred um one thing um one thing I think it would be a part of review is the default rather than sequential so I think the most single structural way to create each of most um African systems uh it is sequencing uh that exists for which I we which I like to call it for no scientific reason ethics that can begin until regulatory approval for some uh countries is granted or the reverse so there are two different bodies asking two different sets of questions about the same set of documents if we can actually uh so so the one thing which I would actually uh point out if we can actually give a parallel review is the default rather than sequencing uh rather rather than submissions in a sequential okay Dr.

SPEAKER_02 32:28

Tara I'm not giving you the magic wand you've got too many problems to fix that magic I was just wondering if I had to so I I'm gonna take that wand and just add two things I think I I would add to to what Nolit had said you know central IRB so so in in many of our countries um and many of our studies right every little hospital has its own IRB and then there's a national IRB on top of that. So not only are things going on sequentially they're starting at little community hospital X to Y to national and it just creates a bureaucracy I think knowledge used that word earlier bureaucracy that it's not clear how it actually benefits patients or how it benefits trials. And yeah the US for example had that problem until they all came together and said hey wait a minute what what are we doing uh here how can we streamline uh that to really encourage um uh our context to start to think about that central IRB uh process as a way of streamlining and then a common application form would would make a whole world of of difference there's a particular difference between SAPRA and MCAZ and you know KPPB everybody's asking for the same thing but it's slightly different slightly different different formats slightly different ways so if we if we could do those three things I think it would be a game changer so parallel processes central IRB common application uh form uh that is online uh and uh you know um uh audit ready traceable accessible to everyone in every uh country regulator ethics etc uh it would really be a game changer for speeding up research on the continent um and just lastly to say you know the research on the continent yes we think about international sponsors but our main passion as well is domestic research right all of these bottlenecks and costs mean that a young person in Lagos cannot even fathom developing a drug all the way to clinical efficacy. They just can't do it right so if we solve this this is really about solving this for us um and then obviously there'll be a lot of additional uh benefits but make it easy for somebody in Uganda to do a multi-country trial where they self-sponsor right um that 3% of trials it doesn't all have to come from Western farmer it could be us right you know it could be us saying you know how do I repurpose drug acts to treat this condition in my population um you know how how can I work with a colleague in another country to do an HIV trial uh with already commercially licensed uh drugs etc so really streamlining the process for us to be able to do better easier uh research as well you know Dr. you've you've done it again where towards the end of our discussion you've raised something that I just want to talk about some more so I'm I'm definitely calling you back but we have to end this um and and it's about you know where you talked about um domestic uh uh development you know with the African continent I think it's a podcast on its own and we need to do a deep dive but I want to give you the last word to say someone listening to what we've been uh talking about um what did they think or ask that they've never done before could you just yeah shared a few thoughts on that yeah um you know maybe the things that I would like the community listening to take take home uh you know for the general public realizing that there's a bit of a hidden race before clinical trial uh starts uh and it takes longer than it should in many countries and in our focus is particularly in in Africa and the the uh people paying the price are us patients we're we're all participants patients in one or the other uh who needs the the treatments and so the the cost is ultimately uh borne by us uh the population and then for scientists industry uh sponsors you know this startup timeline is not fate right it's it's maybe you know we can all change this right it's a function of preparation submission quality as knowledge talked about regulatory processing so parallel uh uh processing and then having partners who really understand the importance of those timelines of those KPIs what do they mean if I don't meet this how does it affect my country's competitiveness uh how does it affect my ability to do uh global uh trials and then for the policymakers because their remit is making sure their population is is safe right uh really thinking about you know this is doable we did it once before uh and uh we can do it again and make that the standard uh playable uh we could do it in 90 days uh versus almost a year almost 260 is 300 days um if we're intentional uh there's really no reason we can't build a system uh that does does that and then lastly for researchers and sites being prepared is a competitive advantage um uh really understanding the industry the business the business uh model um uh you know it's a little different in sort of grant focused uh research there's a lot of overlap but there's some differences time is important time means therapies don't get to patients in in good good time so being ready having your contracts uh uh ready understanding the budgeting uh having strong budgeting templates always having your CVs your SOPs you know we we talk about and and you guys are probably sick of me saying being ordered ready all the time right having everything uh in place uh and and ready and those kinds of sites are the sites that will be uh you know ready to to win and really drive up uh Africa's participation in process so many last words but but I'll I'll end end there oh I think Wolfred we can't hear you I I acknowledge over to you uh you know any last words from you uh for you um I you have uh make sure that they're short um uh I think the goal um it's not um place of recognition um it is clear requirements coordinated review uh no wasted emotion between a participant and a trial uh could actually change their life um as I've pointed out the issue to do with the parallel is a picture um earlier on so what we basically need these are clear requests coordinated review and um so that list we don't waste uh any time uh between the time we receive a protocol and the time we hit our um uh face to pay face to face to patient face to face wonderful doctor I'm giving you one last sentence to close this off a sentence one thank you no just just to say I mean all of this and and you know the the regulatory science component is so important um yeah uh all of this is so critical to make uh Africa competitive just having clear regulatory playbook um is super essential for for competitiveness wonderful Dr.

SPEAKER_00 41:25

Sara thank you so much it's been a pleasure having you knowledge thank you for um coming on the podcast for the first time it's been great and thank you so much for for your time this brings us to the end of our podcast until the next time thank you and bye bye