Fundamentals of Pharmacovigilance

This course offers an in-depth exploration of drug safety and pharmacovigilance, focusing on risk management, compliance, regulatory communication, and the unique aspects of the Indian Pharmacovigilance Program. Participants will gain expertise in signal detection, audits, and international PV regulations, preparing them for key roles in ensuring drug safety and compliance.

Module 1 : Foundations of Drug Safety

  • Definition and scope of pharmacovigilance
  • Historical background and evolution of PV
  • Roles and responsibilities of PV professionals
  • Pharmacovigilance databases and reporting systems

Module 3 : Audits and Compliance

  • Types of PV audits (internal and external)
  • Audit planning and preparation
  • Conducting audits and assessing findings
  • Reporting audit results

Module 5 : Indian Pharmacovigilance Program

  • PVPI structure and functioning
  • Reporting ADRs in India
  • Collaborations with other PV programs
  • Challenges unique to the Indian context

Module 2 : Risk Management Strategies

  • Risk assessment methodologies
  • Signal detection and signal management
  • Risk minimization strategies
  • Benefit-risk assessment

Module 4 : Regulatory Communication and Risk

  • International PV regulations (e.g., ICH E2E, E2E(R3))
  • Risk communication strategies
  • Labeling and package insert requirements
  • Safety communication channels

Module 6 : Ensuring Compliance

  • PVPI structure and functioning
  • Reporting ADRs in India
  • Collaborations with other PV programs
  • Challenges unique to the Indian context

Certificate In FCPM [ Online ]

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

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ 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
Clinical on-site exposure