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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 9 Track 1: Proven Techniques in Selecting and Implementing a Regulatory Information Management Solution that Fits Your Organization

Session Chair(s)

Michiel  Stam

Michiel Stam

Management Consultant

MAIN5 Gmbh & Co. Kgaa, Germany

Information management has revolutionized the complete gamut of regulatory submission processes and how teams that build or contribute towards developmental and commercial applications conduct their work. In the past decade, the pace of innovation has continued to accelerate, expanding the potential for greater efficiency, enhanced connectivity, and better tools to achieve stronger regulatory compliance. The benefits brought forth by state-of-the-art systems and strong business processes can be achieved by organizations of any size, and in key instances, growing businesses have a distinctive advantage in establishing fit-for-purpose solutions that match organizational structure and operations. This session highlights the significant benefits of implementing integrated solutions and good document management practices at any stage of product development, and best method to ensure the most important industry technological gains of the last 20 years are integrated seamlessly into any organization.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify strategies and methods for selecting the best RIM solution based on business requirements
  • Apply tried and true processes to maximize the benefits of a complete RIM solution in order to ensure good document management and high-quality on time submissions
  • Initiate a change management plan to ensure buy-in and adoption from all stakeholders


Joel  Alvarez, MS, MSc

The Missing Link: RIM Assessment Strategies that Get Results

Joel Alvarez, MS, MSc

Bill & Melinda Gates Medical Research Institute, United States

Global Regulatory Compliance, Operations and Labeling Leader

Milagros  Vitor-Butzen

The Human Factor: Untap your Organization’s Potential

Milagros Vitor-Butzen

Takeda Vaccines, Inc., United States

Associate Director, Regulatory Operations

Dee  DeOliveira, RAC

Winds of Change: How to Harness People, Process, and Technology to Transform the Status Quo

Dee DeOliveira, RAC

Cerevel Therapeutics, United States

Senior Director, Global Regulatory Operations

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