Regulatory Submissions, Information, and Document Management Forum

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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

Senior Director, Global Regulatory Operations Head

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

Rimsys, United States

Director of Product

Addressing the Unique Challenges of RIM for Med Devices

Brian Williams

KPMG, United States

Advisory Managing Director, Life Sciences

Case Study: Implementing RIM Business Process Automation at a Biopharmaceutical Company

James Nichols

Lorenz Life Sciences Group, United States

Director of Sales & Account Management