RAPS Euro Convergence: A preview

RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest | 06 May 2021 |  By 

RAPS Euro Convergence is just around the corner. The three-day conference devoted to European healthcare product regulations and regulatory issues kicks off Monday 10 May, running through 12 May. Pre-conference workshops begin Friday, 7 May.
This year’s all-virtual program will feature more than 130 expert speakers and more than 40 educational sessions. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA), national health authorities, notified bodies, and the medical device and pharmaceutical industries.

“This is a critical time for everyone working with European regulations,” said Sabina Hoekstra-van den Bosch, PharmD, FRAPS, regulatory strategy principal at TÜV SÜD, who is also a member of RAPS’ board of directors and one of three conference committee co-chairs. “Health authorities, regulated industry, and notified bodies all must work together to implement new regulations, so it is key to have all three groups represented.”
After a yearlong delay due to the global pandemic, the EU Medical Devices Regulation (EU MDR) is set to go into effect this month. The In Vitro Diagnostic Regulation (IVDR), another extensive regulatory overhaul, will take effect next year. And Brexit, the UK’s withdrawal from the EU, became official this year.
“Europe’s regulatory environment for medicines, medical devices, in vitro diagnostics (IVDs) and other healthcare products, was already undergoing major changes even before the COVID-19 emergency,” said conference committee co-chair, Gert Bos, FRAPS, PhD, CSO, executive director, and partner with Qserve Group in the Netherlands. Bos is also RAPS president. “Those changes are still happening.”
“With such sweeping regulatory changes and much uncertainty still remaining, RAPS Euro Convergence provides an important opportunity for the European regulatory community to exchange information, ideas and best practices,” said Eric Klasen, life sciences expert in regulatory and QA solutions, Waypoint LS, and the third committee co-chair.
Of the 40+ education sessions, 22 will cover medical devices, 11 will be devoted to IVDs, and 12 will pertain to pharmaceutical regulations. See the full interactive agenda.
The event will begin with a Plenary Opening Debate, covering developments in EU legislation with respect to the medical device, IVD, and pharmaceutical sectors, and featuring expert panelists from the EC, EMA, the Danish Medicines Agency, the Dutch Health and Youth Care Inspectorate, notified bodies, BSI and TÜV SÜD, and others.
Other highly anticipated sessions include:
Medical devices IVDs Pharmaceuticals In addition, four preconference workshops will be held Friday, 7 May, covering postmarket reporting, clinical studies in PCMF, risk management, and software as a medical device.


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