David Roe

David Roe, Novartis Pharma AG - Qepler Summits And Conferences

David Roe

Global Technical Steward, NTO Manufacturing Science & Technology
Novartis Pharma AG
Basel, Switzerland
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide.

Dave has been the Global Technical Steward for Combination Products and Medical Devices since October 2013. In this role, Dave oversees all global operational and maintenance activities related to Medical Devices & Combination Products at Novartis globally and his team supports multiple development programs and projects containing medical devices and or combination products.

He is also the operational representative for the Medical Device and Combination Product Expert Network at Novartis, as well as member of several other cross-functional boards.

Dave joined Novartis in 2009, through the acquisition of Nektar Therapeutics and has contributed to the industrialization and commercialization of several programs in that time.

He has over 25 years of experience in R&D, and Manufacturing within the Consumer electronics, Medical Devices & Pharmaceutical Industry.

Before joining Novartis, he held several roles in fortune 100 companies including West Pharmaceuticals, Apple and General Electric focusing on the development and commercialization of pharmaceutical delivery systems and consumer electronics.

He studied Engineering and holds both a Bachelors and Masters of Science in Plastics Engineering, from the University of Massachusetts, USA. He is aslo a gradute of the General Electric Chemicals and Materials Leadership program and is a certified Six Sigma Black Belt.

Related Sessions:

Qepler - 2nd Annual Drug/Device Combination Products Summit thumbnail Details

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
BLOCK: LCM CHALLANGES WITH DRUG/DEVICE PRODUCTS.
CASE STUDY: Workshop.

This workshop will provide an overview of the journey and lessons learnt by the first company to achieve a certification of their QMS system and product against the EU MDR. The presentation will be focused in two parts – firstly an overview of the adaptation of the quality system to incorporate and address the elements required under the MDR followed by a discussion and reflection of the challenges and strategies used to successful upgrade and certify an inhaler device platform supporting both commercial and development products.

  • Strategy used to adapt a quality system to the MDR.
  • Gap assessing your quality system and implementing a plan to adapt and upgrade to continuously improve and meet the MDR and other Global HA requirements.
  • What does ready look like? Key lessons learned on the transition.
  • Discuss the product strategy employed and the challenges faced in adapting a legacy platform product to the MDR, which also required an up classification.
  • Outcomes, challenges and strategies for transition and implementation.
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