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Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.


Session 5: NB Update: EU MDR Article 117 Current Impact to Drug Delivery Devices

Session Chair(s)

Kirsten H. Paulson, MS, RAC

Kirsten H. Paulson, MS, RAC

  • Senior Director, Global CMC Medical Devices
  • 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

Speaker(s)

Ibim B. Tariah, PhD

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