RAPS European Council (REC) Webcast: Peer Insights on the Real Impacts of MDR Postponement and Remote Audits on our European Regulatory Community

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Tuesday, 30 June 2020 (4:30 PM) - Tuesday, 30 June 2020 (6:00 PM) Central European Time (CET)

Member: FREE
Nonmember: FREE

Your participation in the regulatory community is vital. The RAPS European Council (REC) is offering this webcast for free so that global regulatory professionals maintain access to valuable knowledge about issues currently impacting our industry.


2020 has certainly been a year of unexpected change and transformation around the globe—and the regulatory community has been no exception. Join us for four brief presentations from European peers with insights and perspectives about how to prepare and optimize your organization for MDR postponement and remote audits in the COVID-19 landscape. 

  • Effective Use of Our MDR Delay Year—State of Being: Explore the latest developments, new guidance, best practices and key lessons learned from a growing number of successful MDR cases. 
  • Update on Clinical Evaluation and Other Relevant Topics from Brussels: Understand the impact of the recently published MDCG-Guidance documents in the clinical area (MDCG 2020-5 and MDCG 2020-6) on the MDR clinical data requirements, as well as recent developments at EU level.  
  • EU MDR Regulatory Challenges for Combination Products: Gain insights on EU MDR classification and requirements for combination products with the implementation of MDR Art. 117, with a distinct focus on DDC and the major challenges. 
  • Are You Ready for Your First Remote Audit? Get answers to top questions and hear best practices around navigating details to master your remote audit in a new COVID-19 landscape. 

A Q&A session will be provided at the end. 

This event is brought to you by the RAPS European Council (REC) to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credits.

This webcast is available to global regulatory professionals for free. 

Looking for More Euro-Centric Regulatory Content and Professional Development?

RAPS Euro Convergence 2020 convenes 26-28 October 2020 in Brussels, Belgium and will offer expansive content designed by European regulatory affairs professionals for European regulatory professionals. A wide range of current issues facing medical device, pharmaceuticals, IVD and regulatory professionals will be covered, as well as general subjects that impact all professionals in the healthcare products space. Learn more and register.

Join our RAPS Community

RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Learn more about RAPS membership.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speakers:
Gert Bos, PhD, cto, QserveGroup Medical Device and IVD Consultancy
Sabina Hoekstra-van den Bosch, PharmD FRAPS, regulatory strategy principal, TÜV SÜD
Stephan Affolter, regulatory + quality intelligence manager, Ypsomed AG
Angelina Hakim, founder and ceo, QUNIQUE GmbH

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