Pharmacovigilance Courses

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• Pharmacovigilance Services
• Pharmacovigilance or drug safety in lay man
  language. Pharmacovigilance is the science that
  connects to the detection, collection,
  monitoring, assessment, and prevention of the
  negative effects of pharmaceutical products.
  Pharmaceutical vigilance mainly involves the
  evaluation of information and facts provided by
  the health care providers. Pharmacovigilance
  excessively focuses on the adverse reactions of
  drugs, defined as the response to an unintended
  and noxious drug. It also includes the
  inefficiency of the drug. Errors like abuse and
  overdose of the medication and drug exposure
  during pregnancy despite the lack of an adverse
  effect are considered to result in an adverse
  drug reaction.
• Pharmacovigilance is extremely important to
  determine the usability and the effects of any
  drug. Any pharmacovigilance service centre
  undergoes special clinical research training
  through several clinical research courses. This
  is one of the major departments of any
  pharmaceutical company. Any pharmacovigilance
  process mainly consists of four stages.
• These stages include
• Pharmacovigilance Detection Process This is the
  first stage in the vigilance process of any
  drug. It begins with the safety information that
  comes from several sources, which may be either
  solicited or unsolicited. Those that are received
  as a result of the targeted data collection form
  the solicited data sources. These include
  clinical trials with one or three phases and
  post-marketing, including interventional and
  non-interventional studies and research.
  Solicited sources also include organized systems
  that have a well-defined public health purpose
  and a scientific and clinical purpose. Solicited
  sources also include personalized programs
  forum-registered drug administration. Unsolicited
  sources are spontaneous and those which are
  received without any form of request. These
  sources generally include regulatory
  authorities, literature reports, patients and
  healthcare providers, license providers,
  internet, journal, books, and other resources.
• Pharmacovigilance Assessment Process After the
  initial collection of all the required data,
  ICSR assessment is conducted. This assessment
  mainly includes
• Triage This phase of potential adverse event
  report involves the major function of
  establishing the validity of an ICSR. Any valid
  ICSR should mainly possess an identifiable
  patient, an identifiable reporter, suspect drug,
  and an adverse event.
• Data Entry Any pharmaceutical company maintains
  its own suitable database. After validation, the
  drug parameters are entered into this safe
  database. The further steps in

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• Pharmacovigilance Services
• data entry include determining seriousness,
  coding the adverse events, assessing causality,
  assessing labeling, and concise and legible
  narrative writing.
• Questioning Process Any clarifications and
  additions discrepancies are raised and cleared
  during this phase of the assessment.
• Reviewing Physicians and other professionals
  review the safety regulations that
• emphasize the seriousness, causality, labeling,
  etc.
• Closure of the case The completed report,
  including all the parameters, is submitted to
  the required authorities. Learn Best Clinical
  Research Course.
• Understanding and Analysing the Drug safety
  profile The data collected is reviewed and
  analyzed to understand the safety profile of the
  drug using a periodic benefit- risk evaluation
  report which includes data collected from all
  forms of clinical trials and spontaneous trials
  for which a risk-benefit analysis is conducted.
  Particular adverse reaction follow-up queries
  are used to get structured information on
  reported suspected adverse reactions. A risk
  management plan and development safety update
  report is also made. Signal analysis is also
  conducted.
• Prevention of the negative effects This phase is
  the final stage of pharmacovigilance. Performing
  minimization of risk activities in order to
  update the summary of the product description, a
  leaflet of patient information, labeling and
  packaging, and legal status of the medication is
  done in this phase. This stage also includes the
  monitoring of this minimization of risk
  activities.
• Collaboration in the field of pharmacovigilance
  forms the foundation of the WHO program for
  international drug monitoring. These reports are
  generally analyzed locally and could lead to
  action within the country itself. The WHO program
  membership of any country helps them keep up
  with similar researches and reports that are made
  worldwide. When there are multiple reports of a
  particular drug, this process may lead to a
  detection of a signal which could be hazardous
  to the human body.
• Ecopharmocovigilance Procedures for monitoring
  the drug concentrations and the ill effects of
  these drugs on the environment lack despite the
  FDA. A concept including environmental
  pharmacology and pharmacovigilance focuses on
  this domain. The activities of
  ecopharmacovigilance include increasing the facts
  available on the environmental effects on the
  drug, use of environmental risk management plans,
  tracking new data on the exposure

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Pharmacovigilance Services to the environment,
risk identification, etc. There are several
pharmacovigilance courses that focus on this
aspect of the field.