RAPS Euro Convergence to address Europe’s top regulatory challenges, say conference co-chairs

RAPS' LatestRAPS' Latest
| 08 October 2020 | By Zachary Brousseau 

Bos and Hoekstra-van den Bosch

RAPS’ 2020 Euro Convergence kicks off in less than three weeks. The conference, which had originally been scheduled to take place in Brussels in May, will be held all online, 26–30 October. It follows the successful, first-ever virtual RAPS Convergence last month, and comes at a crucial time for the life sciences sector in Europe.

Even before the COVID-19 pandemic, regulatory professionals working with products for the European market had their hands full. The pending implementation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) already had manufacturers rushing to be ready. Questions proliferated about whether there would be enough notified bodies certified under the new regulations, and how much capacity they would have. Rapidly evolving medical innovation continued to push drugmakers to develop better medicines, but also brought new challenges in how to regulate such products. Brexit created even more uncertainty.

Euro Convergence gives the European regulatory community an opportunity to come together to share ideas and information when such exchanges are needed most. “There are common challenges and common questions, so a forum like this is very important,” said Euro Convergence Committee Co-Chair Sabina Hoekstra-van den Bosch, PharmD, FRAPS, regulatory strategy principal at TÜV SÜD, as well as a member of the RAPS board of directors.

The conference will cover wide range of top regulatory topics related to medical devices, in vitro diagnostics (IVDs) and pharmaceuticals, the event’s three defined subject-matter tracks. Attendees will hear from more than 100 expert speakers including officials from the US Food and Drug Administration (FDA), The European Medicines Agency (EMA) and several notified bodies. In addition to the more than 40 education sessions, there also will be multiple virtual networking opportunities so attendees can still benefit from connecting with peers and colleagues.

While the pandemic may have pushed the MDR implementation deadline back a year to May 2021, concerns about device companies’ and notified bodies’ readiness remain. Manufacturers are struggling with difficult-to-solve issues, says Euro Convergence Committee Co-Chair Gert Bos, FRAPS, PhD, executive director and partner with Qserve Group in the Netherlands, and RAPS president-elect. “People will be looking at each other like, ‘well, how have you solved it? What solutions can we find?’”

For IVD manufacturers, the changes are even more sweeping than for MDR. “The shift in the requirements is much bigger,” said Hoekstra-van den Bosch. “Especially for the manufacturers who [previously] did not need to involve a notified body, there is an awful lot of work to do.” There are still only a handful of IVDR-designated notified bodies. “If you’re not on board with one of them now, it will be a challenge,” said Bos.

Hoekstra-van den Bosch also pointed out that IVDR and MDR have consequences for pharmaceuticals, as well, and could impact the way drugs and devices are co-developed. Other pharma-related hot topics to be covered at Euro Convergence include regulation of biosimilars, orphan drugs and gene therapies.

Regardless of area of specialization, the 2020 Euro Convergence brings the European regulatory community together at a time of seismic change and unprecedented uncertainty. “Everyone is aware that there will be big, big issues to solve,” said Bos. “But together, we will try and see how we can protect the patients of Europe and the rest of the world.”

For more information or to register for RAPS’ 2020 Euro Convergence, visit the conference microsite.

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy