Rockville, MD, USA, April 22, 2021 (GLOBE NEWSWIRE) -- The Regulatory Affairs Professionals Society (RAPS) will hold its annual RAPS Euro Convergence, a three-day conference devoted to European healthcare product regulations and regulatory issues, 10–12 May. This year’s program will feature more than 130 expert speakers and more than 40 educational sessions taking place all online. 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 next 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
- Clinical Evaluation, Monday, 10 May, 12:00–13:00 CET
- Economic Operators, Wednesday, 12 May, 12:00–13:00 CET
- Postmarket Surveillance, Wednesday, 12 May, 15:00–16:00 CET
IVDs
- IVDR Debate - Regulation Changes, Monday, 10 May, 17:00–18:30 CET
- Pressure cooker: Fast Track to IVDR Compliance, Tuesday, 11 May, 10:00–11:00 CET
- IVDR Implementation Best Practices and Challenges, Tuesday, 11 May, 12:00–13:00 CET
- Companion Diagnostics: The Path for Companion Diagnostics Under IVDR, Wednesday,12 May, 17:00–18:00 CET
Pharmaceuticals
- Innovative Regulatory Decision Making - Optimised Development Strategies, Tuesday, 11 May, 12:00–13:00 CET
- Article 117, Wednesday, 12 May, 10:00–11:00 CET
- Digitalisation in Health Care/(Real World) Evidence and Innovative Technologies, Tuesday, 11 May, 15:00–16:00 CET
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.
Reporters, bloggers and other members of the media who wish to cover all or part of RAPS Euro Convergence should contact Zachary Brousseau, senior manager, communications, RAPS, at zbrousseau@raps.org.
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide. www.RAPS.org
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