Output Of The Post Market Surveillance (PMS) Plan - Pepgra.com

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OUTPUT OF THE POST MARKET SURVEILLANCE (PMS)
PLAN
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales_at_pepgra.com
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Today's Discussion
OUTLINE OF TOPICS
In Brief
Need for PMS
PMS What it Involves PMS What it Offers PMS
Plan Outputs
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In Brief

• The new European Union (EU) post-market
  surveillance (PMS) plan would act as a detailed
  tool for benefit-risk evaluation for medical
  devices. If the PMS is appropriately structured
  and executed, the EU-PMS plan would act as an
  intrinsic player in setting up a novel framework
  for proactive safety evaluation of medical drugs
  and devices.

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Need for PMS
Post Marketing Surveillance (PMS) can be defined
as the process of identifying and gathering
information pertaining to medications or medical
devices after it has been approved by the
concerned authorities such as the Food and Drug
Administration (FDA) in the US. Post market
surveillance is executed by several different
organization types, as well as agencies. Recent
instances in terms of safety issues within public
health that revolved around medical devices have
also accorded much emphasis on the necessity to
enhance the European Union medical device
regulation (EU-MDR).
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PMS What it Involves
Considering that the process of drug approval
comprises of phase I, II and III trials,
post marketing trials are often referred to as
phase IV trials. PMS comprises of a systematic
monitoring of drugs and medical devices as they
are utilized in actual real-world
scenarios. This is in contrast to controlled
clinical settings during pre-marketing Clinical
trials wherein the conditions of the study are
strictly controlled. Though randomized clinical
trials (RCTs) that have the propensity to lower
variability are beneficial in evaluating the
effectiveness of one drug or device as compared
to the other.
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PMS What it Offers
PMS offers information which is highly valuable
with regards to utilizing drugs within special
population of patients. Studies that involve an
RCT that have been executed prior to marketing
comprise exclusively of subjects who match the
preset exclusion and inclusion criterion, thereby
creating a population that is largely
homogenous. Therefore, PMS is only the medium of
acquiring information on teratogenic and
mutagenic impact of drugs amongst humans.
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PMS Plan Outputs
The objective of a PMS plan is to act as a
scheduled system which is organized for executing
planned yearly activities on the basis of which
the PMS organizational processes are
executed. As per the EU-MDR, there is a need to
have a specific PMS plan for every product within
an organizations product portfolio. The
outputs from the PMS plan would result or impact
diverse post-market documents. For instance,
following a review of national registries (an
aspect of the Post Marketing Clinical Follow-up
PMCF plan), a manufacturer might recognize a
new issue in terms of safety with the product
which might impact diverse post market documents
update to clinical evaluation report (CER),
development of corrective and preventive actions
(CAPAs).
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