EU MDR IMPACT TO DRUG DEVICE COMBINATIONS AND DEVICE CLASSIFICATION

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Archived Webinar

EU MDR Impact to Drug Device Combinations and Device Classification

Jeremy Moore, Associate Director, Medical Device and Combination Product Quality
AbbVie

Recorded on December 9, 2020

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

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PRICING
This webinar is available for download for $249.

TARGETED AUDIENCES
EU MDR Regulatory
Global Regulatory Affairs
Regulatory Affairs
Combination Products

INDUSTRIES REPRESENTED
Medical Device
Pharmaceutical

Presenter:

Jeremy Moore, Associate Director, Medical Device and Combination Product Quality
AbbVie

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:

Brooke Akins
Division Director, Life Science Programs
+1 (312) 224-1693
bakins@q1productions.com

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