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Pharmacovigilance

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Pharmacovigilance

Pharmacovigilance (PV) plays a central role in the health care system which involves assessment, monitoring and understanding the various chemical interactions amongst drugs and their impact on humans. Pharmaceuticals and Biotechnology medicines in tandem are designed to cure, prevent and holistically treat diseases.

Apart from the assessment, pharmacovigilance also becomes significant in dealing with risk aspects of Adverse Drug Reactions (ADRs) that could eventually harm patients. Hence, the study of pharmacovigilance is the utmost important for aspirants when dealing with drug therapy.

Course Goal
An aspirant would be able to have a comprehensive concepts on:
  • Collect
  • Collate
  • Analyze data to arrive at an inference to recommend regulatory interventions
  • Communicating risks to healthcare professionals and the public
Curriculum
Module: I: Introduction
  • Different definitions of pharmacovigilance
  • Scope of pharmacovigilance
  • Historical overview
  • Pharmacovigilance and its development
Module: II: Pharmacovigilance in clinical trials
  • Practice and different medical treatments
  • Pharmacovigilance in clinical practice text file
  • Improvements needed in post marketing surveillance text file
  • Methodologies for pharmacovigilance
  • Regulations in pharmacovigilance in clinical research
  • Ethical and legal aspects of clinical trial in pharmacovigilance
  • Patent Specifications
  • Terms and terminology
Module: III: Pharmacovigilance Management: Risks & Importance
  • Pharmacovigilance in Marketing Management
  • Risk Management-A European Regulatory View Resource
  • Drug Marketed without Food & Drug Administration (FDA) Approval Resource
  • Post approval marketing practices: Drug safety and pharmacovigilance resource
  • Good clinical trial practices and regulation
  • Drug marketing and promotion resource
  • Ethical & safety considerations resource
  • Informed consent process resource
Module: IV: Adverse Drug Reactions and Safety Reports
  • Adverse Event/Adverse Drug Reactions
  • Pharmacovigilance signal detection
  • Spontaneous reporting in UK
  • Spontaneous reporting in Germany
  • Spontaneous reporting in United States
  • Drug safety in Pregnancy
Module V: Pharmacovigilance Compliance-Planning Programs & Drug Risks Benefits
  • Basics of pharmacovigilance and its terms
  • Pharmacovigilance planning
  • Pharmacovigilance management compliance
  • Drug risk management & studies
  • Pharmacoepidemiology and drug evaluation
  • Economic evaluation of pharmaceuticals and clinical practice
Need Help?
  • 04066844855

    09989330160

  • Email: writeus@syntenylifesciences.com

  • Windsor Plaza, Vegitable Market Road, New Nallakunta Center,Hyderabad.

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Many students and entrepreneurs often restrict themselves in learning and at the same time mastering a specialised area of biological studies rather than taking up the holistic study of complete life sciences.

Contact Us
  • Windsor Plaza, Vegitable Market Road, New Nallakunta Center,Hyderabad.

  • Email: writeus@syntenylifesciences.com

  • 04066844855

    09989330160

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