Hello Colorado!
Our RAPS Colorado Chapter is looking forward to partnering with the San Francisco Bay Area Chapter tomorrow, Wednesday, 13 October 2021 (12:00 PM) - (1:00 PM) Mountain Time (US & Canada) on this Webcast.
We are pleased to have our Featured Speaker Kim Torluemke, RAC, CEO, KT Regulatory Consulting, LLC from the local Colorado area as well!
Description:
Developing a flexible and adaptable regulatory strategy is key to supporting the development of safe and effective 3D printed medical devices that help improve the quality of life for patients. The complexity of developing medical devices using 3D printing technology is challenging, given the need to navigate the latest U.S. regulatory pathways. This webcast will discuss the U.S. pathway for approval and will highlight the global regulatory landscape for obtaining approval of 3D printed devices in Europe, Australia, and Canada.
The topics covered will include:
- Understand the history of regulations governing the development of 3D printed medical devices and the impact of warning letters that shaped the regulations.
- Learn about the U.S. pathway for approval and how it differs for Europe, Canada, and Australia.
- Obtain insights on how the regulations need to change to address ongoing industry challenges for getting products to market.
There will be a Q&A session at the end. If you prefer, you may also submit any questions you might like answered during the presentation to colorado.raps@gmail.com, and the RAPS Colorado Chapter will be happy to pass them along to the speaker to address during the Q&A session.
Learning Level: Basic
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.
RAC holders may claim 1.0 RAC recertification credit.
REGISTER HERE
We look forward to having you join!
RAPS Colorado Team
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Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
President, AMWA Rocky Mountain Chapter
Communications Manager, RAPS Colorado Chapter
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.comwww.linkedin.com/in/lindseysummershttps://linktr.ee/biopharmasleuthhttp://www.greenkeyllc.com/ph/Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Clinical Development / Medical Affairs & Monitoring / Epidemiology / Health Outcomes
Ecosystem: Pharma-Life Sciences/Healthcare/Accounting-Finance/Info Tech/HR-Office Support
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