Pharmacovigilance Internship Training With Stipend At Hyderabad
The focus of the lectures will be mainly on the following topics:
» History and over view of pharmacovigilance
» Introduction and responsibilities: USFDA, EMA and CDSCO
» Pharmacovigilance in India
» Clinical Development process
» Different phases of clinical Trials
» 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
» Introduction to safety databases and different types
» Importance and procedure of duplicate check
» Case booking or initiation
» Introduction to MedDRA and WHODD
» Narrative writing
» Case quality check, Medical review and its submission.
» The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
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