In the rapidly evolving regulatory environment, digital transformation initiatives are critical to enhancing compliance, efficiency, and data integrity. However, successful implementation hinges not only on technology but also on effectively managing change.

This forum will explore the pivotal role of change management in driving regulatory digital transformation, emphasizing how structured approaches can mitigate resistance, foster stakeholder engagement, and ensure sustainable adoption, including data governance.

Attendees will gain practical insights into integrating proven change management techniques and tools, such as Artificial Intelligence (AI), within their digital transformation programs. Using examples from my organization’s current Regulatory digital transformation program, we will discuss frameworks for aligning organizational culture, communication strategies, and training plans to support seamless transitions.

Furthermore, the session will highlight key performance indicators (KPIs) essential for monitoring progress and measuring success. Attendees will learn how to identify and track metrics related to user adoption rates, data quality improvements, and overall program effectiveness.

Speaker: Linda Chong, Strategic Initiative Lead - Regulatory Data, Digital, and AI, Sanofi

Linda Chong has over 20 years of experience within the Pharmaceutical industry, specifically Regulatory Information Management (RIM), Global Submission Management, and Data Governance, including organizational change management. She is currently the Strategic Initiative Lead with a focus on Regulatory Data, Digital, and AI enablement at Sanofi. She has provided leadership, strategy, and guidance for global R&D data, process, and system initiatives that include end-to-end RIM capabilities, IDMP, data unification, change management, etc. She led the creation and implementation of a new R&D Data Governance and Stewardship program at her most recent role. Previously, she was a speaker on "Building Efficiencies in a Global Electronic Environment” and “Streamlining Processes and Data Exchange across R&D” at other industry conferences. Linda has a Bachelor's Degree in Information Systems Management from The College of New Jersey, as well as a Master's Degree in Business Administration.