Philadelphia Chapter: Reflections on EU MDR Article 117: Challenges and Opportunities from Pharma an

When:  Jul 16, 2019 from 5:00 PM to 9:00 PM (ET)

Student: $10
RAPS Member: $20 
Nonmember: $30

On 5 May 2017, the European Commission adopted the Medical Device Regulation 2017/745. The new regulation will come into full application on 26 May 2020. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.

Come join others from your local regulatory community to hear three different perspectives on the impact these changes will have for manufacturers.

EU Medical Device Regulation: The Impact on Combination Products and Industry Challenges

  • Overview of EU Medical Device Regulation (MDR), which becomes effective 26 May 2020
  • Impact of EU MDR Article 117, a provision requiring Notified Body review of the device constituent of single-entity combination products
  • Challenges in interpreting Article 117 requirements, industry’s approach to addressing this uncertainty, and recent developments including EMA’s Q&A document

Preparing for Compliance with EU MDR 2017/745 and Article 117

  • Address common questions around EU MDR 2017/745 Article 117
  • Review how to prepare Technical Documentation in compliance with EU MDR 2017/745 
  • Understand how the current Essential Requirements align with the new General Safety and Performance Requirements (GSPR’s)
  • Discuss upcoming EMA draft guidance on the quality requirements for regulatory submissions for medicines that include a medical device (drug-device combinations)

EU MDR Opportunities and Challenges for Pharma and Device organizations from a Risk Management Perspective

  • Discuss Risk Culture Differences between Pharma and Device Organizations
  • How to ensure your suppliers and partners are supporting your compliance with EU MDR 
  • Best practices for incorporating risk management through the lifecycle and Integrating into 13485

This event is coordinated by the RAPS Philadelphia chapter and is intended to encourage knowledge sharing and community development. A dinner and refreshments will be available for all attendees and RAC holders may 3 RAC recertification credits.

NOTE: For security purposes, attendees will be required to show photo ID to enter the facility.

Thank you to our program sponsors, Network Partners.

Feature Speakers:

Ratinder Dhami, senior scientific advisor, regulatory affairs, Network Partners
Douglas Mead, senior director, regulatory affairs, Janssen (Johnson & Johnson)
Hemal Mehta, associate director, regulatory affairs, Janssen (Johnson & Johnson)
Darin Oppenheimer, executive director, global regulatory affairs and clinical safety, Merck



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