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Session 9 Track 1: Proven Techniques in Selecting and Implementing a Regulatory Information Management Solution that Fits Your Organization
Session Chair(s)
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
Speaker(s)
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
The Human Factor: Untap your Organization’s Potential
Milagros Vitor-Butzen
Takeda Vaccines, Inc., United States
Associate Director, Regulatory Operations
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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