Vol. 41 | Vol. 41(5) - September / October 2023 | REGULATION

Solving the last (or first!) mile of global RIM transformation: improving local Affiliate engagement

by cyb2025

STEVE GENS
Gens & Associates, Morrisville, Pennsylvania, United States

ABSTRACT

Building on his recent talk at Amplexor (ArisGlobal)’s annual global BE THE EXPERT conference, Steve Gens of Gens & Associates reports the top-level findings of a far-reaching new regulatory study into the evolving role and challenges at a regional and country level. Improving local Affiliate effectiveness is critical for a true end-to-end global regulatory information management capability.

Most life sciences companies have made global regulatory information management (RIM) system and process adoption a strategic priority, and improving Affiliate engagement is paramount to achieving this goal. That’s because the overall aim is to create a high-performing regulatory organisation with high data quality, end to end, which the company can rely on and use as the basis for increasingly strategic decisions.

ABOUT THE AUTHOR

Steve Gens is the managing partner of Gens & Associates, a global life sciences consulting firm specialising in strategic planning, RIM program development, industry benchmarking, and organisational performance.
sgens@gens-associates.com
https://gens-associates.com/

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