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.

Ultimately, achieving Regulatory excellence depends on a combination of process optimisation, effective global systems, high data quality, and enhanced Affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment.

However, transforming information management at a local Affiliate level - across this last (or arguably first) mile of the internal regulatory matrix - has been notoriously challenging up to now.

Highly manual processes, specific local market requirements, tool usage inconsistencies, as well as the obvious barrier of language differences, have often meant a gap in information visibility globally which adds risk to key regulatory processes.< ...