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Regulatory Submissions, Information, and Document Management Forum

Session 4 Track 1: Regulatory Thought Leadership on the Industry-Wide Scale

Session Chair(s)

Jake  Doran

Jake Doran

  • Head of Global R&D IT
  • Bausch Health, 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 : Attendees will be able to: 1. Recognize the HeRO forum as a cross industry collaboration between Top-20 sponsors 2. Discuss the implications of the changing role of regulatory operations in the industry 3. Evaluate the value of a harmonized data standard for different product transfer deals


Peter  Terbeek, MBA

Making Sense of RIM – Driving Consistent Understanding of Terms, Processes, and Metrics

Peter Terbeek, MBA

  • Senior Director, Regulatory Operations
  • Astellas, United States
Sheila  Mahoney Jewels, MBA


Sheila Mahoney Jewels, MBA

  • Independent Workforce Advocate
  • LifeSciHub , United States
James  Nichols

Collaboration for Implementation of Standards: How the IRISS Forum Brings Value

James Nichols

  • Chief Product Officer
  • Phlexglobal, United States
Bernie  Coney, MA

HeRO Forum – Industry Collaboration Addressing the Evolving Challenges of Regulatory Affairs Organizations

Bernie Coney, MA

  • Principal Consultant
  • NNIT, United States