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Training in Pharmacovigilance

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.

In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

# Course Content:(Course code: GAC002)

  • Introduction to Pharmacovigilance
  • Role of WHO in Drug safety monitoring
  • EU perspective
  • US perspective
  • ICH Guidelines
  • Safety monitoring in pre-approval stages
  • Post-marketing surveillance methods
  • ICSR(Individual Case Safety Reports)
  • Aggregate reports
  • Coding Dictionaries
  • Case processing in-class assignments
  • Narrative writing
  • Real time project
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