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11
Risk
Management
f luence of subjectivity enhances the reliability of risk
analyses and risk management at large.
Conclusion
Subjectivity emerges in ICH Q 9(R1) (8) as a concept
that must be addressed to improve the effectiveness
of risk management, and in turn the pharmaceutical
quality system. In fact, O'Donnell challenges "can an
organization do effective Risk-based Decision-mak-
ing if its risk assessments are highly subjective?"
(16). As mentioned by experts, acknowledging and
addressing subjectivit y are crucial for making in-
formed and effective risk-based decisions, ultimately
leading to improved product quality, patient safety,
and product availability. Indeed, subjectivity casts a
long shadow on QRM and, by extension, the pharma-
ceutical industry as a whole.
Updates included in the revision to ICH Q9(R1) re-
f lect the growing recognition of the significance of
subjectivity in risk management within the pharma-
ceutical industry. By incorporating language related
to bias, evidence, data, information, knowledge, and
knowledge management, the revised guideline ap-
pears positioned to enhance the objectivity and reli-
ability of risk assessments. These changes included
in ICH Q9(R1) provide an opportunity to shine a light
on this issue by emphasizing the need to address sub-
jectivity and its connection to business outcomes and
patient safety.
However, while subjectivity has emerged as im-
portant in ICH Q 9(R1), significant work remains to
develop a clear and shared understanding of what
subjectivit y is, when subjectivit y might exist and
what to do about it when it does. These topics will
be the focus of future research by the authors. Such
research is also expected to explore subjectivity in
other industries and study best practices. In addition,
it is anticipated that training on this topic, and ex-
ploring emerging technologies and methods, would
be beneficial.
Disclaimer
The views expressed in this article are those of the
authors and are not necessarily those of any organi-
zations with which the authors are affiliated.
References
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