Why is Literature Search Important in Drug Safety and Pharmacovigilance

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Why is Literature Search Important in Drug Safety
and Pharmacovigilance
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Why is Literature Search Important in Drug Safety
and Pharmacovigilance


Pharmacovigilance is a domain that works
completely on drug safety through collection,
detection, assessment, monitoring, and prevention
of adverse effects associated with pharmaceutical
products. It is a science that needs no
introduction these days, thanks to increased
vigilance in pharmaceutical drug discovery and
development, as well as the introduction of new
products to the market. For Drug safety or
pharmacovigilance, data will be collected from
different sources to understand and assess the
drug, either in its development stage while doing
clinical trials or after releasing it into the
larger population to understand its safety and
efficacy in a wide range of populations. Literatu
re search, monitoring, and screening As we
discussed above, the goal of literature search
and monitoring is to identify individual case
safety reports and any possible changes to the
benefit-risk profile of the substance that is
being monitored, particularly in relation to the
detection of new safety signals or emerging
safety issues. Marketing authorization holders
should perform medical device regulation
monitoring on their products from day one of
product authorization until they are active,
whether the product is in the market or not. All
the medical literature published globally and
locally should be monitored and screened for all
the adverse events reported in that literature
for ICSR processing, as the medical literature is
an important source of information for the
identification of suspected adverse reactions to
authorized medicines. .
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Why is Literature Search Important in Drug Safety
and Pharmacovigilance

• As we discussed above, the goal of literature
  search and monitoring is to identify individual
  case safety reports and any possible changes to
  the benefit-risk profile of the substance that is
  being monitored, particularly in relation to the
  detection of new safety signals or emerging
  safety issues.
• Our experts work with you to understand the
  requirements and develop a search strategy based
  on your global and local literature data
  collection requirements. We will work with you to
  understand the purpose of your requirement, if it
  is for ICSR reporting, signal detection, or
  aggregate reporting, and provide you with a
  solution that meets the regulatory requirements
  while being compliant on timelines.
• Schedule a discussion with our healthcare and
  life sciences experts to learn more about the
  criticality of literature search in Drug Safety
  and Pharmacovigilance.
• Read the full blog to know more
• https//www.cigniti.com/blog/literature-search-dru
  g-safety-pharmacovigilance/

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