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Hello. My name is Farai Moyo,
and I'm a pharmacovigilance
specialist at GSK.
Today, I'm going to talk to
you about patient centricity
and the framework that
we have implemented
in the safety
department here at GSK.
0:17
I'm going to describe the
pilot project that led to
the formation of the
patient centricity team
and the creation
of the framework.
I'll close off with lessons
learned and the future direction.
0:34
To lay the foundation of how
we got to this framework,
I want to emphasize
the importance of
patient centricity within
pharmacovigilance.
Patient centricity refers to
putting patients
at the center of
all safety-related activities
and decision-making processes.
It emphasizes understanding
and addressing patient needs,
preferences, and
experiences to improve
medication safety and
overall healthcare outcomes.
Patient centricity is
essential throughout
the life cycle of a
medicinal product.
Remember that this is
not one-sided either.
There are benefits
to industry as well.
To guide industry,
there are some roadmaps
and special interest
groups from ISoP
and pvnet that serve as
forums to share best
practices and experiences.
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Regulatory initiatives
are increasingly
prioritizing patient involvement
to enhance safety measures,
improve communication,
and ensure effective risk
management strategies.
Regulatory bodies like EMA, FDA,
IHI, and ICH are driving
patient-centric approaches.
For adverse drug
reaction reporting,
the EMA enables direct
patient reporting of
suspected adverse events
throughout the EU,
and the IHI developed a mobile
application for patients
to report medicine side effects
and access drug information.
For benefit-risk assessment,
the FDA guidance
emphasizes including
patient perspectives in
benefit-risk profile of
medical devices, and
the ICH guidance
incorporates patient perspectives
into therapeutic context
and benefit-risk assessments
for marketing applications,
and the IHI framework integrates
the patient preferences
on benefits
and risks into medicinal
product decision-making.
For risk management,
EMA guidance stresses
patient input in designing
and implementing
risk minimization measures
and safety communications.
The EMA: PV legislation
promotes collaboration with
patient organizations to improve
preventable harm from
medication errors.
There is a lack of systemic
global frameworks supporting
