EU MDR Impact to Drug Device Combinations and Device Classification
Wednesday, December 9, 2020 | 11 AM CST
This webinar will include a 45 minute presentation and 10 to 15 minutes of Q&A.
- EMA Guidance surrounding Article 117 and Drug-Device Combinations
- Definition of a single integral product
- Impact to on-market drug-device combination products
- Impact of updates, changes, or additions to current products
- Key points of a robust combo product development and regulatory strategy
- Application pathways for Drug-Device Combinations
- Notified Body Opinion Process and timeline
- Expectations of a Notified Body
This webinar is available to single attendees for $249.
For teams, three logins are available for $395.
Use your webinar registration as a credit toward the upcoming EU MDR & QMS Implementation Conference.
EU MDR Regulatory
Global Regulatory Affairs
Jeremy Moore, Associate Director, Medical Device and Combination Product Quality
Jeremy Moore is an accomplished Operations, Quality and Regulatory Compliance Leader with 20 years of Diverse experience across industries and functional roles. About 10 years ago, Jeremy found himself unexpectedly in a quality role and has been hooked ever since. His quality experience spans the industrial supply, medical device, and combination products. In his current role Jeremy is responsible for quality and compliance activities for AbbVie’s portfolio of Medical Devices and Combination Products. In this role he has led a cross functional team in the evaluation, assessment and implementation of EU MDR requirements including Quality System, Post Market, and Development activities including Article 117 devices.
For More Information, Contact:
Division Director, Life Science Programs
+1 (312) 224-1693