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Atlanta Chapter Webcast: Brexit and EU IVDR – Are You Ready?

1.5
RAC Credits
Thursday, 08 October 2020 (12:00 PM) - Thursday, 08 October 2020 (1:30 PM) Eastern Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.

Description

The European Union’s In Vitro Diagnostics Regulation (IVDR) replaces the existing In Vitro Diagnostics Directive (IVDD) beginning 26 May 2022, which is not as far out as it seems. The new regulation’s requirements are much more prescriptive and stringent than the IVDD, so manufacturers will need to begin preparing now to transition their devices to certify under the IVDR. IVD companies have the duration of this transition period to update and adjust technical documents and action plans to meet the standards.

Participate in this webcast with two industry experts, Sue Spencer and Dr. Julien Senac, Ph. D., on a Brexit update and presentations on EU IVDR strategies to help you navigate the new regulation’s higher level of scrutiny. 

Learning objectives for this webcast: 

  • Understand the current impact of Brexit on CE Marked IVD devices.
  • Differences between IVDR and IVDD 
  • How IVD companies can approach their compliance initiatives. 

The webcast will conclude with a Q&A session. 

This event is brought to you by the RAPS Atlanta chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credits.

Learning Level: Basic- Intermediate

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals and 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. 

Find out more about RAPS membership today.

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:
Sue Spencer, head of IVD, Qserve Group
Julien Senac, Ph.D., global director - IVD focus team, TÜV SÜD

Register