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Interactive Workshop: Upskilling for Successful Digital Transformations in Regulatory Affairs and Clinical Operations
Session Chair(s)
Helena Corte-Real Correia, PhD
Regulatory Portfolio Data and Content Lead
F. Hoffmann-La Roche Ltd, Switzerland
Maria Florez, MA
Senior Consultant
Tufts Center For the Study of Drug Development, Tufts Univers, United States
Digital transformation not only requires technical skills and the ability to use the latest technology; it also requires soft skills and mindset changes to be able to adapt to new technologies (for example, ML and AI) and new environmental factors (for example, the presence of vast amounts of data). In this workshop, we will look at the components and key skills needed for successful digital transformation within the Regulatory Affairs and Clinical Operations functions. The discussion will be centered around the following questions: • What is our vision for the future of Regulatory Affairs and Clinical Operations? • Where are we headed? • Where should we focus our efforts? • What skills and capabilities do we need to develop? • How do we work together to reach our vision? The workshop will begin with a review of skills and components required for successful digital transformations. Next, session attendees will take part in an interactive game/simulation (The Chocolate Bar) to exercise those skills. Some of these skills include data literacy, product ownership, feedback looping and iterative thinking, operating within a set of constraints, costumer value, team leadership, communication and collaboration. The workshop will close with a review of learnings from the game. We will distill themes and discuss how the skills and processes employed in the game have real-life applications in their day-to-day work.
Learning Objective : Introduction to the key skills,strategies for successful digital transformation uncovered by case studies from Tufts Roche and Pfizer. Awareness of a Future Skills Curriculum for reg affairs & ops professions required for transformation. Experience a pilot Future Skills Curriculum or mini-training module aimed at supporting the process of upskilling individuals in areas viewed as critical to DT.
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