Transcript
00:00:02 Speaker 1
Welcome to Chasing Compliance, the GLOBAL regulatory podcast, where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy, from bench to bedside. Today we are chatting with Violet Chazovachii. Violet has spent almost a decade in the biomedical technology field. As a graduate researcher at the University of Michigan Ann Arbor, she focused on developing surface coatings to optimize microparticles for vascular targeted drug delivery. After earning her master's degree, she joined GLOBAL's CER internship program in 2021 and has advanced to the role of lead medical writer, where she continues to contribute to high-impact regulatory submissions. Violet recently earned her RAC, Regulatory Affairs Certification, in Medical Devices. Thank you for being here, Violet. On this episode, we are discussing RAPS Convergence 2025. We sent a team to this conference a few weeks ago and had a wonderful experience connecting with regulatory affair peers and learning the latest developments and trends in US and global healthcare regulations. Violet was one of our teammates on the ground and has some great insights from the week. So let's dive in. So Violet, let us know how was your experience at RAPS?
00:01:13 Speaker 2
Yeah, thank you, Rachael. So RAPS, oh my gosh, there's so much I could say. Eye-opening, invigorating, grounding. That's honestly how I'd sum up my experience at RAPS. There was this real sense of duality for me. On the one hand, our team went in with a clear business development goal, connecting with potential partners, exploring collaborations, and expanding our visibility. But on a personal level, it became a lot more. I've just entered that mid-level phase of my regulatory affairs career, and this conference really felt like a coming-of-age moment. For the first time, I wasn't just observing or supporting projects behind the scenes. I found myself contributing to real discussions about strategy, risk, and where industry is headed. I was in a room full of VPs, consultants, CEOs, lawyers, and directors, and realizing that I could hold my own in those conversations and be a voice amongst my colleagues and my peers, that was incredibly validating.
Something that really struck me was how many different gears make this regulatory ecosystem move. So there's the writers, there's the reviewers at the notified bodies, the auditors, the policy makers and engineers who drive a lot of the innovation. And seeing how all those pieces interlock, it gave me a new appreciation for the bigger picture that we're a part of here at GLOBAL. More than anything, I think RAPS 2025 made me pause and reflect on who I want to be professionally. Not just someone who ensures compliance, but someone who can help shape it. Shape how regulatory science evolves and how we as a community can stay grounded amidst all the flux and change.
00:03:16 Speaker 1
What a great perspective and what a cool way to step into a conference like that to see, that bird's eye view of how things function, what a big machine it all is and how everybody plays an important part and how, as medical writers, you step into that and, how those of us kind of on the outskirts supporting that are part of the process as well to make sure that regulations are strong and businesses and organizations are moving through the process and submissions with success. So that's great.
I know that you both worked the floor and went to a couple of sessions. What sessions stood out to you?
00:03:56 Speaker 2
Yeah, there were a lot of enriching sessions. There was so much that was being talked about on AI. They demystified the AI Act. There were sessions talking about the FDA shutdown and impacts to submissions that require user fees. The sessions that I found to be most impactful - there was one on patient-centric writing and then also one on the role of the payer, the insurance company during pre-market workflow. So I'll start with the patient-centric writing topic. So Karen Jaffe, who is an MD, who was diagnosed with Parkinson's disease. Karen was the lead panelist in this session and she talked a lot about the importance of making sure the patient is centered at every stage of the regulatory process. And some would argue that, you know, MDR and FDA already do a good job of that. But Karen really opened my eyes to ways that we could incorporate outcomes that patients care about, outcomes that are relevant to patients at every stage of our benefit-risk analysis. So Karen is with the Michael J. Fox Foundation for Parkinson's Disease Research, and she's played a role in developing clinical trials, being a part of different patient advocacy groups, and allowing those groups to really inform what is defined as clinically relevant. A lot of the times, doctors decide what's clinically relevant, and I think that's important, and doctors definitely have the knowledge and expertise to do so, but it's not necessarily comprehensive of how a device or medicine is really impacting the patient. So what I took away from that as a writer is that I can be an advocate for the patient, even as I'm drafting my clinical evaluation reports or PMCF documents. And one way to do that is to advocate that the manufacturers use patient-reported outcomes whenever possible. What a lot of devices we measure safety and performance in terms of clinical physician-reported metrics, but we sometimes ignore things like patient quality of life, daily activity scores, patient comfort and I think there's room that to incorporate that into our S&P objectives. Yeah. So all of that to say, yes, the role of regular regulators and statisticians, that's that shouldn't change, I don't think. But they definitely are the experts in the methodology of measuring outcomes. But patients really define what's relevant, which outcomes are worth measuring. So I remember Karen saying something along the lines of, in Parkinson's, a neurologist might prioritize the UPDRS motor scores, but a patient might argue that what is really life changing to them is just being able to button their shirt or write legibly again. So that doesn't mean we need to rewrite our whole statistical analysis plan, but it does mean that we might need to change the focus to a functional independence endpoint rather than just tremor amplitude. So yeah, that's really insightful and that's something that I want to incorporate more into my writing as a CER writer and strengthen the post-market realism for patients. Patients, they shouldn't design trials, but they should definitely help define what a successful trial or a successful post-market follow-up for device looks like, essentially. So another great session was by Chris Lyle, and he discussed the importance of regulatory and payer strategy. And so honestly, for me, payer strategy was a new term. The payer...as important as they are. The payer, which is the insurance company, is not someone that we think about a lot when we're drafting these submissions. But it's actually a commercial pitfall that some clients, and maybe especially smaller startups, are not aware of when they're looking to get a device to market. Beyond satisfying the FDA and the notified bodies in the EU, the insurance company is really looking for a level of rigor in how we design our PMCF and how we design our pre-market trials before they decide to pay for a device. And what I learned was that even if a product is approved, it doesn't necessarily mean that the insurance company is going to cover it, which ultimately means that it's not going to reach patients and it could get pulled from the market. And so it was exciting to learn that because I saw this as a way that we can help our clients plan success from the very start. There's a lot of devices that are like in the US and maybe the cells aren't necessarily where the client wants them to be, but they're trying to get it to the EU market. And I think going back through the documentation and going to the pre-market stages and seeing how the trials are designed, how the success criteria is defined, it can really help de-risk the submission and ensure that the devices get adequate coverage and can reach patients.
00:10:16 Speaker 1
Nice. Yeah, I really like the takeaway of how different perspectives make everybody better, right? So as medical writers, considering the patient perspective as well as the medical professional, as well as what the regulatory process needs really makes the entire output that much better. So yeah, I really like that. I think that's great. And what a wonderful session to offer at a conference like this for folks to attend and then go back and integrate into different roles across the industry. The ripple effects of that will be felt for a long time. That's wonderful. With RAPS, overall and with your attendance, what would you say was your main takeaway?
00:11:01 Speaker 2
The greatest takeaway I have from RAPS is that the regulatory affairs industry is a giant machine with a lot of moving parts, and at times it can feel overwhelming. And that's what I got from a lot of my discussions, like even just impromptu discussions that I would have over coffee with someone in the hallway. None of us have the whole picture. None of us can keep track of how fast everything is moving, whether it mean AI, the element of the AI being introduced, or the new proposed targeted revisions to MDR. We all need each other. We all need to hold hands through this process and remain connected so that we can keep the machine running and keep providing safe innovation to patients. And I think my biggest takeaway is how, as a consultant, right now, clients are probably kind of drowning and feeling overwhelmed by all these changes that are happening. And I think as a consultant, our job is to provide that grounding for them. Not necessarily to pitch business at them, but to let them know that like we're able to step in the weeds and help them get a sense of stability amongst all the evolution.
00:12:32 Speaker 1
Yeah, I think that's a really good point. And I think, you know, that ties into kind of what GLOBAL does as a, you know, wider organization and how we can be consultants and be supports for others in the industry. Like you said, it's a huge industry. There's a lot to it. There's a lot going on. There's a lot to stay on top of. So what would you say from what you saw at RAPS and the conversations you had, how do you see GLOBAL as a team helping others in this space?
00:13:02 Speaker 2
Global has so many strengths because we have writers from all like different walks of life and different disciplines. But I think what we bring most to the table that I that I I think I was we were commended for this by the current client clients and current people in our network at the conference is our ability to just meet clients where they are and our patients to partner with them rather than act as a vendor. I think a lot of times we're all being flooded with a lot of information daily. There's like everything feels like a buzzword. But we definitely bring a sense of humanity and connection to the job. And I think that's what a lot of people are looking for. They want to know that we actually care about their business, not just what we can get from them. And I think GLOBAL has done a good job as a small CRO of being that like familial voice amongst a lot of commercial voices. So at Global, we can really step in and we're not just concerned about the compliance and just getting a document to the finish line, getting notified body acceptance and see more. We're concerned with the success of our client's business. And that's why it really stood out to me this this session about the importance of considering the payer, the insurance company, when you're looking at your premarket trials and your premarket clinical evidence package, because it's really painful to see to work on a device for a client that maybe they were planning to put it on the EU market, but then it turns out the cells aren't good. The insurance company is not paying for it, and so they're just going to have to pull it even off the US market and not sell it at all. And I think, oh, how could we have stepped in earlier in the process and made sure like this was going to be a commercial success? And sometimes clients don't know what they need, but it's our job to keep learning about these different facets, to learn not about just satisfying regulators, but satisfying the payers, the insurance companies, to make sure our client's business is truly successful and everyone's happy.
00:15:33 Speaker 1
Yeah, that's awesome to hear your perspective, especially given your expertise as a medical writer and what you see within the industry and how as an organization, we can step in and offer another perspective. Like we talked earlier, how it's so important to have different perspectives and bringing that all together makes the work much better and elevates it. So I really love the way you framed that and how GLOBAL really supports clients and partners to make their work that much better. That's wonderful. So we recently posted some information on our blog around 510K's, and I was wondering, is there anything that wraps on this particular topic that would be relevant to share?
00:16:16 Speaker 2
Yeah. Actually, now that you mention it, it makes me think back to the session about, you know, some of the political turmoil that's happening in the US and how that's led to the FDA shutdown. There were a lot of manufacturers and startups who were concerned about how this was going to impact their 510k submissions and how the delays were going to impact their portfolios. And what I learned was that, you know, only time can tell how long this checkdown is going to last. We can't accelerate the process, but where we can step in, is helping our clients make the most of the time, the downtime that they have now, and ensuring that they have a really strong application so that when the FDA opens back up, they face less barriers. So what this means is that we would enter as regulatory affairs strategist. We would look at their applications and determine whether they're eligible for third party review. So a third party could review the submission. Ultimately, the FDA still has to approve it, but they're not going to have to do all the intensive review. If they use a third party. Company like Intertek or TUV. To really do the heavy review that's necessary.
00:17:56 Speaker 1
Nice. Yeah. And I like the way that you framed that where definitely can be a challenging and sometimes frustrating time to deal with delays and things outside of our control. But the way you frame that of looking at it like, all right, well, how can we use this time and get something positive out of it? That's really great. Thank you for sharing that. Anything else on your mind around RAPS or anything that you heard or saw there that you would want to share that we haven't covered already?
00:18:22 Speaker 2
Yeah, so. Some other themes that I took away from the conference was really like thinking about cross-functional, not just being between different teams or departments, but becoming cross-functional as an individual. And that's something that I'm looking to do as I grow as a professional. There was a lot of talk about how AI and digital tools are changing the evidence landscape. But as I would dig deeper into these discussions, I would find out that what I need, what would help make my job easier as a CR writer is not necessarily what these tools are providing. And it could be something as simple as can the AI technology extract safety and performance outcomes from a publication that uses more than two patient cohorts. And I, as I was talking to a lot of different software developers, I was finding out that that's not something they've done yet. So what I'm, what I was realizing is that I think in these discussions, it's good that we have these discussions with, you know, the computer programmers or with like the design engineers, but it might help if we actually learn some of these capabilities ourself, that might mean that I might need to start learning how to code. I do know a little bit of JavaScript in C, but I think for to reach the next level and to make AI very impactful, it's going to take those who use the tools actually being a part of the design process. And so that's something that I'm interested in doing. And I think at Global, where we have a lot of fast learners, that's something that we could do as well.
00:20:28 Speaker 1
Yeah, dust off some of those old coding skills and dig into it, especially with an exciting new technology. I think the combination of, like you said, the great team we have that learns quickly and is curious and wants to move into new spaces and just the great expertise and education on our team, I think there's probably some really wonderful insights that we can discover together. So that's exciting. I look forward to hearing more. Love that.
00:20:55 Speaker 1
Well, thank you for listening to this episode of Chasing Compliance, and thank you again to Violet for joining us. If you are interested in learning more about how GLOBAL can support your regulatory writing and consulting needs, please visit us at www.globalrwc.com or e-mail us at
[email protected]. And if you liked today's episode, please share it and leave a review. Until next time, we wish you continued compliance.
