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Clinical

PHARMACOVIGILANCE

What is Pharmacovigilance?

Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of Adverse Effects, particularly long term and short term side effects of medicines. Pharmacovigilance looks at all available information to assess the safety profile of a Drug.

COURSE CONTENT

  • Pharmacovigilance
  • Clinical Development process
  • Different phases of Clinical Trials
  • History and overview of Pharmacovigilance
  • Introduction and responsibilities of USFDA, EMA and CDSCO
  • Pharmacovigilance in India
  • Adverse Events and its types
  • Drug Safety in clinical trials and post marketed drugs
  • Different sources of Adverse Events reporting
  • Different types of AE Reporting Forms
  • Expedited reporting and its timelines
  • Different departments working on Pharmacovigilance
  • Roles and responsibilities of case receipt unit
  • Roles and responsibilities of Triage unit
  • Four factors for the reportable case
  • Seriousness criteria of adverse event
  • Expectedness or Listedness of adverse event
  • Causality assessment of the adverse event
  • Importance and procedure of duplicate check
  • Data Entry
  • Case booking or initiation
  • Case processing
  • MEDDRA and WHODD coding
  • SAE narrative writing
  • Case quality check, Medical review and its submission
  • PSUR and its submission timelines

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