June 30, 2020 - June 30, 2020
Date: 30th of July 2020
Time: 16:30h - 18:00h CEST
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 potential consequences of the one-year postponement on MDR implementation.
- 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 credit.
This webcast is available to global regulatory professionals for free.
Join Gert Bos and register now!