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Combination Products Conference
Session 5: NB Update: EU MDR Article 117 Current Impact to Drug Delivery Devices
Kirsten H. Paulson, MS, RAC
- Pfizer, Inc., United States
With less than a year until the EU MDR is effective, many questions remain on how combination products will be affected. This session will discuss late-breaking information on the impact of Article 117 and how companies are preparing.
Learning Objective : At the conclusion of this session, the participant should be able to:
- Analyze regulatory expectations and industry challenges in complying with Article 117
- Discuss considerations for prioritizing portfolio remediation
- Discuss the latest information from EMA and Notified Bodies
NB Update: EU MDR Article 117 Current Impact to Drug Delivery Devices
Ibim B. Tariah, PhD
- Vice President, EU MDR & IVDR Services
- Regulatory & Quality Solutions (R&Q), United States