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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

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

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 7 Track 2: Optimizing Affiliate Engagement: Learnings from a Landmark Affiliate Study

Session Chair(s)

Alison  Buno, MBA

Alison Buno, MBA

Senior Director, Regulatory Submissions

AbbVie, Inc., United States

A comprehensive survey was conducted across over 300 affiliate offices (aka country offices/LOCs) during June-August 2023. Participants responded to questions covering the use of systems across nine individual RIM areas including submission forecast and planning, product registration management, health authority (HA) commitment management, HA interactions, local label management, submission content management, submission archiving, regulatory intelligence, and promotional materials. The session will have three presentations, each by a member of the survey's core research team covering aspects of the study results to share the specific needs and challenges of affiliate offices and how to better address country-level challenges in RIM programs and in ongoing operations.

Learning Objective :
  • Understand the affiliates' perspective on how they can be better supported within their functions
  • Identify key barriers for collaboration and engagement with headquarters
  • Identify opportunities to improve process and system efficiencies


Katherine  Yang-Iott, MS

Overview of the Gens & Associates Landmark Study: Optimizing Affiliate Engagement

Katherine Yang-Iott, MS

Gens and Associates, United States


Greg  Brolund, MS

Think Globally, Act Locally: Why Affiliate Use of RIM Tools Should be Optimized

Greg Brolund, MS

Chicopee Falls Consulting, United States


Kelly  Hnat

We’re in This Together: Partnering with Affiliates to Optimize Global RIM Performance

Kelly Hnat

K2 Consulting/Gens & Associates, United States


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