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Session 5 Track 1: Registration Management
Session Chair(s)
Sarah Powell, RAC
President, Powell Regulatory Services, United States
Registration Management in Medical Device organizations creates challenges that are different than those in a traditional pharmaceutical company. This session will focus on those challenges and solutions that can be applied.
Learning Objective : Describe how identification of medical devices in a RIM system differs from pharmaceuticals Analyze factors within a company that influence viable device identification strategies Apply information in IMDRF CDE Guidance to aid in development of medical device ID standards for RIM systems
Speaker(s)
ID of Medical Devices in Registration Management Systems
Karin Sailor
Consultant , SRO, Inc, United States
Regulatory Information Management System A Strategic Asset
Lana Jokhan Holder, MS
Sr. Project Manager, Life Sciences Solutions Transperfect, United States
Innovative Approach to Aligning Two Disparate Processes Within a Challenging Regulatory Framework
Kanchana Iyer, MS
Senior Regulatory Affairs Specialist, PENTAX Medical, United States
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