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Regulatory Submissions, Information, and Document Management Forum

Session 2 Track 1: Business Impacts to IDMP

Session Chair(s)

Vada A. Perkins, DrSc, MSc

Vada A. Perkins, DrSc, MSc

  • Executive Director, Regulatory Policy and Intelligence
  • Bayer Pharmaceuticals, United States
Explore some of the opportunities and challenges of addressing IDMP integration within the pharmaceutical environment. Discussion topics include collaborative processes and principles for successful assessment and implementation of an IDMP program, along with a case-study from a company perspective to provide lessons learned in their approach to IDMP to deliver business improvements.
Learning Objective : Ability to identify and ultimately plan for a synergistic IDMP/RIM program. Plan for and perform analysis on various processes in order to formulate an action plan for long term compliance. Describe and share with colleagues the long term goal of IDMP, how it's not just about data, as well has how other agency activities come into play.


Sue  Metz

Collaborative Processes for a Successful IDMP Program

Sue Metz

  • President/CEO
  • IRISS Forum, United States
Thomas  Hornbaek Svendsen, MS

IDMP Readiness – Status Based on Pharmaceutical Company Assessments in Europe

Thomas Hornbaek Svendsen, MS

  • Managing Consultant
  • NNIT A/S, Denmark
Christian A. Buckley, MBA, RAC

Sponsor Perspective Case Study

Christian A. Buckley, MBA, RAC

  • Associate Director, Regulatory Affairs
  • Astellas, United States