We can’t wait for RAPS Euro Convergence 2023. Here’s why.
RAPS Euro Convergence 2023 is inching ever closer. The most comprehensive regulatory affairs conference in Europe takes place on 10-12 May in Amsterdam. The co-chairs of the conference programme committee joined RAPS for a chat about why they can’t wait to be back in-person, what they’re looking forward to, tips for attendees and more. The conversation below has been lightly edited for clarity.
Alex Laan: I am the head of the IVD notified body with BSI. I'm about three years into my membership with RAPS. But I've visited many conferences before I was a member.
Siegfried Schmitt: I'm vice president, technical for Parexel. I've been involved with RAPS for well over a decade —mostly, in the beginning, with the publications — and with organizing conferences for a few years now. And certainly I'm very, very pleased to be now in my second year together with Alex, the co-chair for this Euro Convergence event. It's fantastic.
What are you most excited for at RAPS Euro Convergence 2023?
Alex: I'm very much excited to get all stakeholders and all people together in one room, especially in Europe, because there are a lot of things happening at the moment. The EU MDR has enrolled for a year so we can now look back at how that is going. IVDR has also recently been enrolled. RAPS Euro Convergence is very interesting because it brings all of these different peoples from different backgrounds and all together in one room to really sit down and discuss this. So that is I think, within regulatory, one of the nicest things you can have.
Siegfried: We saw last year how important it was for the public to actually attend a conference in person. It was a great success. And so this year we expect to completely sold-out event. And of course that's what we are excited about because it really also shows the importance of this particular event in Europe.
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What is one big issue facing European regulatory professionals that this conference will address?
Alex: In my area of expertise, the IVDs, I think I'm really looking forward to discussing about the Class Ds and how these are made available in Europe and how these are rolled out. Also, I think it will be very interesting to see the current status of EUDAMED and how that is building. I think there is still a lot to develop and means that there's also a lot to discuss.
Siegfried: I think although the pandemic is over, it isn't back to business as usual. A lot of things have changed in the regulatory field and maybe if I can mention just one aspect, then it would be expedited regulatory approvals. I mean, which company wouldn't want to bring their products to market faster? But seriously, perhaps the thing I'm most excited about is the splendid support we are seeing from the regulators. Between the European Commission, the European Medicines Agency or the various national competent authorities, we expect well over two dozen representatives participating in this event. Now that, I think, is outstanding.
Alex: Yes. In addition to this, I think this is an amazing achievement. And as I said, there's so much to talk about. We have recently seen the amendment not only for the IVDs but also for the medical devices, which has been in the waiting for about a year now. And I think we will see the fruits of these amendments over the next year to come. And that certainly will stir up very nice conversations among regulators, notified bodies and manufacturers alike.
What’s one under-the-radar topic you’re excited to hear more about at Euro Convergence 2023?
Alex: Well, I think Siegfried also alluded to this. There are a lot of things happening in the background. Notified bodies are getting prepared, competent authorities are getting prepared. And through the normal channels, a lot of people will not see what is actually going on.
However, during a conference like RAPS Euro Convergence it is possible to have a better understanding of where things actually are, how the European Commission is progressing, how competent authorities are progressing, and how also pharma is progressing. And you can only have a good understanding of that if you really get into discussion with each other. And one of the nice things we have noticed also for this year is the amount of panels. We have a lot of panel discussions and as a result of that you will also see a lot of information that probably you will not see through the regular channels.
Siegfried: To add to this: Of course at the conference you have a device track, you have a pharma track, but there is a lot of overlap. You have all these combination products, for example. And it's important that we don't allow ourselves to get blinkered and look at one side only. And these conferences really provide the opportunity to understand a lot more because they have really got across the whole field here.
The opening plenary session deals with leveraging clinical data. How did the committee decide on this for its opening plenary session and why is it so important?
Alex: Leveraging clinical data is not new. I think, especially in Europe, it's important to understand that at this moment there's still a lot of devices on the market that, based on the medical device directive and the IVD directive, a lot of these devices also conform to the new requirements. Now, although it is very clear that there are a lot of new requirements out there related to clinical evidence, related to performance evidence for IVDs for instance, there's still quite a lot of information, also including real-world data, that manufacturers can take on board when demonstrating the performance and safety of their device. So it is not a new topic, but it is certainly very much a topic which is on the radar with all stakeholders.
Siegfried: And we mustn't forget that during the pandemic some products were developed in phenomenally short time and brought to market and saved millions of people's lives. And there is now a certain expectation amongst the patient population that this sort of continues, in a way. Of course, this is a little bit excessive as an expectation. However, the way to bring more products faster to market, of course, is always based on data.
So to have the discussion about data, where to get them from, what to do with them, and how to benefit the patients in the end, that is a most important aspect here that I see clearly is the perfect thing to discuss during an opening panel.
And in addition to this, I think a topic that is very important and still not enough discussed is the role of postmarket surveillance, the role of real-world data, especially for the data of legacy devices that have been placed on the market. When you take a look at the regulations both for MDR and IVDR, there are requirements that manufacturers need to obtain data also from their legacy devices during the transitional provisions. And you can take a lot of that data on board when demonstrating conformity to the new regulations. So also that is very good to discuss and take on board.
Last year’s conference marked RAPS’ return to in-person events. What did you learn at last year’s event and how did that help you plan for 2023?
Alex: To be honest. I think last year was already very successful because it was the first time that RAPS was again set up for face-to-face where people actually could meet each other. For this year we continue that trend. Although I think it's good to know that there are alternatives to connect with each other —and I think RAPS certainly has conveyed that — at the end of the day, a lot of information is also shared between the presentations in the lobby and that is only a thing you can really do if you're actually see each other face-to-face.
Siegfried: If anything, last year's conference enforced that we were correct to go in-person again because that is how it needs to be. We are simply individuals who need personal interaction to make sure we get the most out of these events. Yes, you can watch a video presentation, but that doesn't allow you to have a chat to someone you didn't know, that you are going to talk to at the coffee, having a glass of wine, whatever. There are so many more opportunities to enhance your network, to learn more, to share and to be part of this group of people. And that needs to be in-person.
Lastly, what’s one tip you’d give someone attending this conference for the first time?
Alex: I think one good tip would be: don't try to be too much overwhelmed because you will see a lot of information at the same time. Try to cherry-pick the best topics and also try to be part of as many panels as possible. I don't want to give the impression that the presentations and the deep dives are not interesting or necessary, but panels, and especially the discussions that arise, certainly will help you get a better understanding of the big picture and how all these different regulations converge with each other.
Siegfried: As I said before, it's not just about attending and learning. It's also about interactions. So what I would recommend is, if you can, come early, attend one of the workshops prior to the start of the conference. And I think importantly, as I said, not just go to the coffee breaks and make new acquaintances, but come to the social events. There is no better opportunity to meet people, and you know, it's fun too. So that's what I really recommend the newcomers to do.
RAPS Euro Convergence unites regulatory affairs professionals and industry partners to share and collaborate solutions for the improvement and advancement of healthcare in Europe. Click here to explore the conference agenda and buy your ticket.