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Drug Safety: Signal Detection and Management in Pharmacovigilance

Drug Safety: Signal Detection and Management in Pharmacovigilance

Upskilling is a better roadmap to success. Enroll in this course to learn critical principles of Biopharmaceuticals through real-life case studies & examples


Course Highlights

  • Flexible final assessments

  • course must be completed with a passing grade of 80% or more

  • 24/7 access to course content

  • voice-overs, easy navigation, progress checks & high-quality animations will help to increase retention of subject matter

Duration: 180 Days

Mode of learning: Online self study

Course Overview

Who should do this course ?
  • Professional working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies

What are the course deliverables ?
  • Identify methods of signal detection and discuss their limitations

  • Describe how to accumulate evidence on a causal association between a drug and an event

  • Specify factors

  • Discuss reassessment of benefit/risk balance in the light of a previously unexpected reaction to a product, and specify actions to minimize riskthat increase the priority assigned to a signal, and describe methods of further investigation

More about this course
  • The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product

  • This online course supplies the student with a guide that will help them understand signal detection and the proper management of approved products. The process for this subject matter is presented in four stages: minimization and risk assessment; prioritization and signal analysis; signal validation; and signal detection. Interventional clinical trials, observational studies of prescription, and their use in the real world, data mining through large databases, and traditional medical assessment of individual spontaneous reports of adverse events, are some of the methods used.

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