Certificate Course in Pharmacovigilance

Pharmacovigilance is critical to ensure the continued safety of drugs, as information on potential harms of a drug is incomplete when the drug is launched. There are stake several stake groups; however, health professionals, drug companies and regulators worldwide play a key role in pharmacovigilance. According to WHO, 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

  • General Overview of Pharmacovigilance
  • Key Terms & Terminologies
  • General & Systemic Principles of Pharmacology
  • Regulatory Guidelines& Laws in Pharmacovigilance
  • Medical Dictionary for Drug Regulatory Activities MedDRA
  • Diagnosis and Management of Adverse Drug Reactions
  • AE/ADR Reporting Systems & Forms
  • Medical Evaluation of Adverse Events
  • Narrative Writing
  • Expedited Reporting Requirements
  • Periodic Safety Update Reports (PSURs) for Marketed Drugs (ICH E2C)
  • Signal Detection Tools
  • Quality System in Pharmacovigilance
  • SOPs in Pharmacovigilance

Mr. Dharmesh Mehta


About Mentor

At PharmaElite, all faculty and teaching staffs are NIPER Alumnus having experience of attempting GPAT & NIPER with Top ranks. we understand the dreams and aspirations that drive each one of you. Our GPAT classes are not just about preparing for an exam; they are crafted to be your stepping stone towards success in the pharmaceutical world. Whether you’re a recent Pharmacy graduate, in your final year, or already navigating the pharmacy landscape, our classes are tailored to meet your needs.

Rs 1,699/-

Rs 3,999/-

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