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Session 4 Track 1: Regulatory Thought Leadership on the Industry-Wide Scale
Session Chair(s)
Jake Doran
Vice President, Digital
Lykos Therapeutics, United States
Regulatory Information Management – We’re all in this together! Whether your company markets hundreds of products or a single product, whether your company markets cosmetics, pharmaceuticals, medical devices, or combination products, or whether your company has hundreds of employees or over ten-thousand, we all have to manage our regulatory information. This session will explore a few of the industry groups that have been formed over the years to help us as an industry work together to solve common problems. More and more we are looking to pre-competitive collaborations to add value to our work. We have the opportunity to look to colleagues and experts from industry, whether they are peers, vendors, or consultants to help us all deal with common issues that face each and every one of us. Join us as we hear from the HeRO Forum; a consortium of Heads of RegOps from top 10 pharma, as well as the DIA RIM Working Group; a group of industry professionals working to identify common elements of RIM and define industry standards accordingly, and an update from the IRISS Forum; a broader organization working across industry and using it’s global footprint to advocate with global health authorities and standards bodies and champion the implementation of standards. Join us for an informative session whether you currently participate in these groups or not and find out how an industry forum may be the right place for your organization to look when it has questions, concerns, issues, or solutions that pertain to Regulatory Information Management.
Learning Objective : -Hear the latest thought leadership thinking on critical RIM questions such as process and data governance, ownership -Identify the wide variety of RIM definitions and terminology -Discuss RIM metrics
Speaker(s)
Making Sense of RIM – Driving Consistent Understanding of Terms, Processes, and Metrics
Peter Terbeek, MBA
United States
Senior Director, Regulatory Operations
Co-Presenter
Sheila Mahoney Jewels, MBA
LifeSciHub , United States
Drug Development Multi-Functionalist
Collaboration for Implementation of Standards: How the IRISS Forum Brings Value
James Nichols
Lorenz Life Sciences Group, United States
Director of Sales & Account Management
HeRO Forum – Industry Collaboration Addressing the Evolving Challenges of Regulatory Affairs Organizations
Bernie Coney, MA
NNIT, United States
Principal Consultant
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