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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 1: IRISS Forum – Hot Topics

Session Chair(s)

Sue  Metz

Sue Metz


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


Chris  Mureithi

IRISS Forum - Hot Topics

Chris Mureithi

Parexel, United States

Manager, Regulatory Implementation (RIM)

Cesar  Vinces


Cesar Vinces

Accumulus Synergy, United States

EU Interim and International Policy Lead

Jake  Doran


Jake Doran

Lykos Therapeutics, United States

Head of Digital

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