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Session 10 Track 1: IRISS Forum – Hot Topics
Session Chair(s)
Sue Metz
President/CEO
IRISS Forum, United States
This session will discuss the following hot topics:
Devices: IMDRF TOC implementation pros, cons, implications for document management, EUDAMED, and UDI implementation in EU.
Implications for RIM: How RIM is viewed differently for device companies vs. pharmaceutical companies.
China-4-China: With promising and increasing trends in the China pharmaceutical industry, CFDA reform and China as ICH membership there is an exciting new opportunity to build a Regulatory Operations network of expertise across this newly forming local industry. This presentation will highlight the China challenges, the opportunities which exist, and how IRISS and key local regulatory leaders are working to accelerate industry knowledge and readiness for regulatory reform.
Dynamic Dossiers: Leveraging the foundation technology already in place and complementing it with emerging technology, such as data extraction and visualization technologies, driven through advanced intelligent business process management, the ability to generate submissions in real time will not be just wishful thinking. A successful development of this model will allow global health authorities to reach into sponsor systems to review information in real time while ensuring the intellectual property of the sponsors is maintained without question. This is a much different model from the current submission model of document collection, publishing, packaging, and physical dispatch (whether paper or electronic) for the review process, but the future of data driven process is now a possibility with the right application of technology and global influence.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Employ the IMDRF TOC Implementation and prepare for implications in implementing a RIM system to manage EUDAMED and UDI
- Identify trends in China pharmaceuticals, CFDA reform, China as an ICH member
- Assess how technology can be applied to traditional submission processes to drive a transformational change to a data driven ecosystem
Speaker(s)
IRISS Forum - Hot Topics
Chris Mureithi
Parexel, United States
Manager, Regulatory Implementation (RIM)
Speaker
Cesar Vinces
Accumulus Synergy, United States
Sr. Director Regulatory Innovation & International Policy
Speaker
Jake Doran
Lykos Therapeutics, United States
Vice President, Digital
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