2023 | November / December 2023

The call for greater inclusion: major new survey finds affiliates desire an increased role in co-designing & transforming global RIM

by cyb2025

STEVE GENS
Managing partner of Gens & Associates

ABSTRACT

For too long, Life Sciences local company affiliates have felt underrepresented in the pursuit of streamlined regulatory information management on a global scale. Now that new research has confirmed this, it’s up to central organizations to determine how to purposefully increase affiliate participation in efforts to improve global regulatory information management (RIM) design so there are no gaps in the data or inefficient processes. Steve Gens of Gens & Associates discusses the findings of a new, far-reaching global regulatory study into the challenges facing affiliates – and what matters to them in the pursuit of solutions.

Achieving Regulatory excellence in Life Sciences companies depends on a combination of process optimization, effective global systems, high data quality, and better Affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment.

ABOUT THE AUTHOR

Steve Gens is the managing partner of Gens & Associates, a global life sciences benchmarking and advisory consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance.

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