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Difference between Drug Safety and
Pharmacovigilance
Drug Safety & Pharmacovigilance are receiving more attention than any these
days. “Drug Safety and Pharmacovigilance” is not a single term. There is a
slight difference between "Drug Safety" and "Pharmacovigilance."
In short, we can say one is reactive, and the other is proactive. One is taking
care of compliance and reporting, and the other is focused on interpreting
signals. Ultimately, both refer to the same function of reporting, gathering, and
adverse drug reactions. The primary difference between Drug Safety and
Pharmacovigilance lies in the value of data generation.
Drug Safety Pharmacovigilance
With the Drug Safety design, data
collected at clinical trials and in the
post-marketing environment is
examined and reported.
Crucial data is highlighted, and
regulatory agencies use this
information to decide which drugs
will be registered and reimbursement
authorities to decide reimbursement.
These choices include weighing up
the risk vs. benefit of different
treatment options, i.e., for the service
that the patient receives from the
medicine, what are the likely chances
in terms of side effects.
The Pharmacovigilance model takes
drug safety to the next level. The
term 'vigilance' links to 'being vigilant,'
i.e., proactively considering the
environment, and identifying signals
and trends, with an enhanced focus
on the post-marketing environment.
The conditions of use have changed.
Patient compliance is variable, and
inclusion/exclusion criteria are not
as tight as in controlled trial settings.
Within the Pharmacovigilance model,
larger and more complex datasets
are being analyzed.
It generates considerable insight
into how drugs are performing in the
real world.
Valuable data is being developed on
how medicines are completing
inpatient sub-populations and
across disease states.
The Pharmacovigilance model
concentrates on establishing signal
detection systems and uses
advanced data analytics to
proactively monitor the entrance of
new medicines to large patient
populations. Real-world evidence is
collected, collated, analyzed, and
turned into penetration which is then
being used during regulatory,
reimbursement, and commercial
discussions on strategic competitive
benefits.
The two words Drug Safety and Pharmacovigilance can be used conversely -
the same primary role is being performed. But Pharmacovigilance is more
encompassing and more strategic.Feel free to share this article with your
colleagues.
This Drug Safety and Pharmacovigilance certification not only shows that you
have the expertise needed for the job or the project, but certifications also
showcases your dedication towards what you do, giving credible proof that you
have full fledged knowledge on the topic. In addition, certification shows that
you are fully committed to your career besides validating that you maintain
the latest information and know-how of the tools when doing your job.
Reference by:
https://sollers.edu/difference-between-drug-safety-and-pharmacovigilance/

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Difference between drug safety and pharmacovigilance

  • 1. Difference between Drug Safety and Pharmacovigilance Drug Safety & Pharmacovigilance are receiving more attention than any these days. “Drug Safety and Pharmacovigilance” is not a single term. There is a slight difference between "Drug Safety" and "Pharmacovigilance." In short, we can say one is reactive, and the other is proactive. One is taking care of compliance and reporting, and the other is focused on interpreting signals. Ultimately, both refer to the same function of reporting, gathering, and adverse drug reactions. The primary difference between Drug Safety and Pharmacovigilance lies in the value of data generation. Drug Safety Pharmacovigilance With the Drug Safety design, data collected at clinical trials and in the post-marketing environment is examined and reported. Crucial data is highlighted, and regulatory agencies use this information to decide which drugs will be registered and reimbursement authorities to decide reimbursement. These choices include weighing up the risk vs. benefit of different treatment options, i.e., for the service that the patient receives from the medicine, what are the likely chances in terms of side effects. The Pharmacovigilance model takes drug safety to the next level. The term 'vigilance' links to 'being vigilant,' i.e., proactively considering the environment, and identifying signals and trends, with an enhanced focus on the post-marketing environment. The conditions of use have changed. Patient compliance is variable, and inclusion/exclusion criteria are not as tight as in controlled trial settings. Within the Pharmacovigilance model, larger and more complex datasets are being analyzed. It generates considerable insight into how drugs are performing in the real world. Valuable data is being developed on how medicines are completing inpatient sub-populations and across disease states. The Pharmacovigilance model concentrates on establishing signal detection systems and uses advanced data analytics to proactively monitor the entrance of new medicines to large patient populations. Real-world evidence is collected, collated, analyzed, and turned into penetration which is then
  • 2. being used during regulatory, reimbursement, and commercial discussions on strategic competitive benefits. The two words Drug Safety and Pharmacovigilance can be used conversely - the same primary role is being performed. But Pharmacovigilance is more encompassing and more strategic.Feel free to share this article with your colleagues. This Drug Safety and Pharmacovigilance certification not only shows that you have the expertise needed for the job or the project, but certifications also showcases your dedication towards what you do, giving credible proof that you have full fledged knowledge on the topic. In addition, certification shows that you are fully committed to your career besides validating that you maintain the latest information and know-how of the tools when doing your job. Reference by: https://sollers.edu/difference-between-drug-safety-and-pharmacovigilance/