| Jim Nichols at Thomson Scientific explains how to address challenges
and achieve success in the management of regulatory information
French intellectual, novelist and essayist Marcel Proust once said:
“The real voyage of discovery consists not in seeking new landscapes
but in having new eyes.” Life sciences companies around the world are
having to find ‘new eyes’ in response to evolving regulatory
requirements. As they start on new voyages of discovery, opportunities
for operational excellence are emerging within the area of regulatory
affairs. What novel concepts have these companies identified that are
leading to regulatory innovations? This article describes a few of the
many key areas that have recently been explored.
IDENTIFYING INFORMATION ALREADY DISTRIBUTED
Companies are looking to simplify the process of preparing and
reviewing content for regulatory submissions and updates;
using official document versions means information can be
identified with confidence, and reused without extensive
review cycles. In an electronic document management system
(DMS) environment, it is typically easy to identify which
documents are internally approved. However, it is not easy to
identify which are externally approved for a given market.
Even when the relationship of the submission to the source
component is tracked, it remains difficult to know if a
particular component, once it was submitted to an authority,
was ever approved, or if that component was made obsolete by
the submission of a replacement. |
