Pharmacovigilance
in India and its Scope
·
PHARMACOVIGILANCE
IN INDIA AND ITS SCOPE
Pharmacovigilance is
the science and the activities that deals with detection, assessment,
understanding and prevention of adverse effect and related events.
Pharmacovigilance activities, misunderstood by some people that
it comes into actuality only post marketing .However, in fact pharmacovigilance
activities play an important role throughout the life cycle of the drug.
What do we mean by the
life cycle of drug? The drug has to go through different phases to be finally
marketed.
The WHO definition of Pharmacovigilance also talks about
activities which are further responsible for detection, assessment,
understanding and assessment of adverse effects. The various activities that
are performed according to pharmacovigilance are Periodic
safety update report or Risk benefit evaluation reportwhich are prepared by the companies to submit
to the regulatory authority during first year of commercialization of the
drugs.
How does the
Pharmacovigilance and its activities helps in detection, assessment,
understanding and prevention?
Pharmacovigilance in India
One of the most
popular courses of ACRI is Pharmacovigilance which would benefit the students
to be partaker of Clinical research industry and also at the same time it would
provide an opportunity to the candidates to develop their skills and also
implement the expertise by working on in-house software project with real life
cases.
3 months of class room training and 1 month practice on
exclusive software training in processing real cases.
What will I learn if I
take up this course?
·
Overview of
Pharmacovigilance (PV)
·
Overview of Aggregate
reports
·
Pharmacovigilance
guidelines
·
Pharmacovigilance
frame work and adverse event reporting methodologies acrosscountries
·
CIOMS working
committee
·
ICSR narrative and its
core content
·
Safety information
document used in Pharmacovigilance
·
Risk Management Plan
(RMP) and Risk Evaluation And Mitigation Strategy(REMS)
·
Pharmacovigilance
softwares used across industry –
·
Life cycle of an ICSR
(steps involved in processing an Individual case safety report)
·
Handling of
Pharmacovigilance audits and inspections
Is this program right?
If you are a Health science graduate and looking forward to work
in an MNC and eager to get knowledge in various real life cases and hands – on
software training, then absolutely yes.
Who can apply?
Applicants are recommended to have one of the following :
|
MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy
& Veterinary Science/MD/MS. Graduate/Postgraduate degree in Pharmacy/
Pharmaceutical Sciences. Graduate or equivalent degree in Nursing/Allied
Health.
|
Job
Prospects
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