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Rockville, MD, USA, May 12, 2021 (GLOBE NEWSWIRE) — RAPS Euro Convergence 2021, the premier annual event for European regulatory professionals, hosted by the Regulatory Affairs Professionals Society (RAPS), wrapped up today after three days of online education sessions, expert presentations and panel discussions, and web-based professional networking opportunities.
Held virtually for the second year, the event drew 370 registrants from six continents and 32 countries. Over the course of 65 sessions, attendees heard from—and had the chance to connect with—168 expert speakers from the medical device and pharmaceutical industries, notified bodies, and national and regional health authorities, including the European Commission (EC), the European Medicines Agency (EMA), the Danish Medicines Agency, and the Dutch Health and Youth Care Inspectorate.
“With the unprecedented disruption Europe’s healthcare environment is currently experiencing—including major overhauls to key regulations, Brexit and the ongoing efforts to mitigate the COVID-19 crisis—Euro Convergence was particularly important and beneficial for the European regulatory community this year,” said Salma Michor, founder and CEO of Austria-based Michor Consulting and Trade Services GmbH, and a member of the RAPS EU Board.
As the medical device and in vitro diagnostics (IVD) sectors prepare for sweeping new regulations, readiness for and compliance with the EU’s new Medical Device Regulation—taking effect this month—and next year’s IVD Regulation were recurring themes. Other key topics discussed included optimizing strategies for drug development and new types of combination products that blur the line between traditional concepts of medicines and medical devices.
Euro Convergence gave regulators, competent authorities, and industry representatives the opportunity for constructive dialogue and discussion. For more details on specific sessions and speakers, see Regulatory Focus news coverage of Euro Convergence 2021.
“I was quite impressed with this year’s Euro Convergence. It was extremely well organized and smoothly run,” said Rainer Voelksen, chair of the RAPS EU board. “It’s even more impressive that this is only the second year RAPS has hosted Euro Convergence completely online. If you didn’t know better, it would be easy to think RAPS has been doing it for years.”
In addition to showcasing the latest innovations from solutions providers around the globe, Euro Convergence 2021 also featured 20 poster presentations. Seb Clerkin, a consultant with GMP Advisory Services in Ballincollig, Cork, Ireland, was recognized for his winning poster in the medical devices category, “Regulatory Requirements for Medical Devices within the UK.” Charlie Mortazavi, senior manager, Sanofi, Paris, won for “Retrospective patients pool data to strengthen gene and cell therapy clinical evidence” in the pharmaceuticals category.
Honorable mentions were awarded to Patience Shabangu, medicine registration officer, South African Health Products Regulatory Authority, Pretoria, South Africa, for “Collaborative reliance in medicine quality and safety regulation: The ‘Sartans’ experience in South Africa-Zazibona countries,” and Alizée Devaux, regulatory affairs apprentice, Panoramic Digital Health, Fontaine, France, for “Patient engagement with digital medical devices: challenges of cybersecurity and data protection.”
Next year’s Euro Convergence is set to return to an in-person format, convening 10–12 May 2022 in Amsterdam. For more information, sign up to receive updates by email.
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
CONTACT: Zachary Brousseau Regulatory Affairs Professionals Society (RAPS) 301 770 2920, ext. 245 firstname.lastname@example.org