Clinical Research, Course In Pharmacovigilance

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Monitoring the safety of medicines in clinical
use is essential for preventing the patients.
Hence, it is necessary to have a well-organized
Pharmacovigilance system. This article summarizes
the need of Pharmacovigilance and available
courses in Pharmacovigilance.
Course in Pharmacovigilance Ensuring the Safe
Use of Medicines
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Aim of Pharmacovigilance
Pharmacovigilance is the set of activities
relating to the detection and understanding of
adverse effects and other drug related problems.
The objective of Pharmacovigilance is to increase
patient attention and care in relation to the use
of medicines. It also aims at providing
consistent and stabilised information to support
public health programmes. Course in
Pharmacovigilance aims for

• Improve safety of patients in relation to the use
  of the drug.
• Medical and paramedical intervention
• Contribute to the assessment of effectiveness of
  medicines
• Promotes understanding and education in
  Pharmacovigilance
• Effective communication to public and health
  professional.

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Need of Pharmacovigilance
A medicine is legally set free for consumption by
the general population after it is released into
the market. There is commercial pressure for the
pharmaceutical industry to find the drugs that
are marketed globally to maximise profit in the
shortest possible time. Because of that
pre-marketing safety issues may be unnoticed and
some medicines will only have been tested for
short-term safety on a limited number of selected
individuals. Therefore, it is essential that
still progressing treatments are monitored for
their effectiveness and more information are
needed about using of medicines in specific
population groups and combinations with other
medicines. The Pharmacovigilance is essential for
some of the other reasons, they are

• Insufficient evidence of safety in clinical
  trials prior to marketing
• Patients dying from medicines
• Adverse drug reactions are expensive.
• To Protect patients from unnecessary harm
• To promote rational use of medicines
• To ensure public confidence

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Pharmacovigilance course
Pharmacovigilance is an integral part of clinical
research. It refers to the assessment and
prevention of adverse drug reaction and needs to
ensure the safety of human beings. Candidates can
pursue both certificate and diploma courses in
the field of pharmacovigilance. The course in
Pharmacovigilance is designed to impart the
knowledge of regulatory requirement of drug
safety. Some of the Pharmacovigilance course are,

• Diploma in Pharmacovigilance This course has
  been structured by the experts and provides an
  understanding of the industry and its functional
  areas. It explains the participant with the
  updated theoretical knowledge and practical
  aspects of Pharmacovigilance. The diploma course
  in Pharmacovigilance provides better industrial
  training and skills, better knowledge of the
  industry and professional training about the
  industry regulations for the candidates.
• Diploma in Clinical research and
  Pharmacovigilance This is an integrated course
  that provides the candidates with a systematic
  understanding of the clinical research process
  and Pharmacovigilance methods. It helps the
  candidate to analyse and achieve the drug
  reaction data for making regulatory decisions
  regarding marketed drugs.
• Diploma in Pharmacovigilance and regulatory
  affairs This course in Pharmacovigilance is
  practically focused and the candidates are highly
  driven by Pharmacovigilance and regulatory
  affairs program. They are prepared with the
  knowledge of the global regulatory view and they
  develop skills necessary for regulatory strategic
  planning.

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