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Session 6 Track 1: Application of RIM in Medical Devices – Challenges and Opportunities for Automation
Session Chair(s)
Vahe Ghahraman, PhD
Exec. Director, Global Regulatory Operations & Intelligence, Apellis Pharmaceuticals, Inc. , United States
This session focuses on topics related to implementation of RIM in medical device settings. It presents unique challenges faced in such implementations and contrasts with those of the implementation for a biopharmaceutical company. A case study on process automation for a RIM business process in a life sciences company is also presented.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify and assess the post-market surveillance trends in medical devices and in-vitro diagnostics
- Define and develop solutions for addressing challenges in implementation of RIM for medical devices
- Observe a case study of RIM business process automation for a biopharma company and develop strategies for implementing similar cases
Speaker(s)
Digital trends in post market surveillance for medical devices (and IVDs)
Adam Price
Director of Product, Rimsys, United States
Addressing the Unique Challenges of RIM for Med Devices
Brian Williams
Advisory Managing Director, Life Sciences, KPMG, United States
Case Study: Implementing RIM Business Process Automation at a Biopharmaceutical Company
James Nichols
Director of Sales & Account Management, LORENZ Life Sciences Group, United States
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