Drug Safety Essentials

This course provides a comprehensive foundation in pharmacovigilance and drug safety, covering essential concepts such as ADR classification, signal detection, safety monitoring, benefit-risk assessment, and adverse drug event reporting. Participants will learn to prepare key regulatory reports like DSURs and PSURs, ensuring compliance with global standards.

Module 1 : Basics of Pharmacovigilance and Pharmacoepidemiology

  • Introduction to pharmacovigilance
  • ADR classification and reporting
  • Signal detection and management

Module 3 : Safety Evaluation

  • Structure of Periodic Safety Update Reports (PSURs)
  • Signal detection and risk assessment
  • Interaction with regulatory authorities

Module 5 : Adverse Drug Event Reporting

  • Case report collection and evaluation
  • Aggregate analysis
  • Reporting timeline

Module 2 : Drug Development Safety Monitoring

  • Purpose and components of Developmental Safety Update Report (DSURs)
  • Data collection and analysis
  • Regulatory requirements

Module 4 : Benefit-Risk Ratio

  • Benefit-risk assessment methodologies
  • Comparative analysis
  • Communication strategies
Certificate In FCPM [ Online ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Batches Starting From 

August 2024
Enroll Now For Early Bird Offers
in Both Mode
Certificate In FCPM [ Offline ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play

Get to work on live projects

Face-to-face guidance by PM (Project Manager)

Clinical on-site exposure

Enroll Now