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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
SRO, Inc, United States
Consultant
Regulatory Information Management System A Strategic Asset
Lana Jokhan Holder, MS
Life Sciences Solutions Transperfect, United States
Sr. Project Manager
Innovative Approach to Aligning Two Disparate Processes Within a Challenging Regulatory Framework
Kanchana Iyer, MS
PENTAX Medical, United States
Senior Regulatory Affairs Specialist