×
Back to Agenda
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)
Karin Sailor
Consultant , SRO, Inc, United States
ID of Medical Devices in Registration Management Systems
Lana Jokhan Holder, MS
Sr. Project Manager, Life Sciences Solutions Transperfect, United States
Regulatory Information Management System A Strategic Asset
Kanchana Iyer, MS
Senior Regulatory Affairs Specialist, PENTAX Medical, United States
Innovative Approach to Aligning Two Disparate Processes Within a Challenging Regulatory Framework
Have an account?