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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Member: $10 Nonmember: $25
Description
Are you ready for the UDI regulations in US, EU, China, Australia, Saudi Arabia, Korea, Singapore, Taiwan, and more? As Unique Device Identification (UDI) becomes a globally recognized and required addition to medical device labelling regulation, your UDI program must be sustainable and flexible. It is equally important for your system to allow application of varying and sometimes conflicting UDI requirements while also ensuring compliance with multiple international regulations. Unfortunately, regulatory compliance is only part of the UDI challenge. The UDI benefits will only be achieved when its use is adopted throughout the medical device supply chain and in the health care system’s EHR and track and trace processes.
This presentation will highlight the new countries' compliance dates for UDI. Additionally, the presentation will show similarities and differences in global UDI regulations, the impact on supply chain practices, and DI adoption challenges in health care facilities.
This presentation will feature a Q&A session in the middle and end of the webcast.
This event is brought to you by the RAPS Chicago chapter and the RAPS Twin Cities chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.
Learning Level: Intermediate
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.
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 Speaker: Lena Cordie-Bancroft, president, Qualitas Professional Services, LLC.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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Cancellation Policy: Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at support@raps.org.