Advanced Pharmacovigilance and Drug Safety Management

This course is designed for professionals seeking in-depth knowledge of pharmacovigilance practices, adverse drug reactions, and safety reporting. Participants will gain expertise in risk assessment, regulatory compliance, and effective communication strategies related to medicines safety.

Module 1 : Introduction to Pharmacovigilance and Pharmacoepidemiology

  • Understanding the importance of pharmacovigilance in healthcare
  • Overview of pharmacoepidemiology and its role in drug safety
  • Introduction to adverse drug reactions (ADRs) and safety reporting

Module 3 : Management Systems and Drug Dictionaries

  • In-depth study of pharmacovigilance management systems (e.g., Argus)
  • Utilizing standardized drug dictionaries (e.g., MedDRA) for coding ADRs
  • Practical exercises on data entry and retrieval

Module 5 : Seriousness, Expectedness, and Causality Assessment Criteria

  • Defining seriousness criteria for adverse events
  • Determining expectedness based on product labeling
  • Applying causality assessment tools (e.g., Naranjo scale)

Module 7 : Complaint Handling and Risk Identification

  • Handling patient complaints related to drug safety
  • Identifying potential risks through real-world evidence
  • Role of complaint data in risk minimization strategies

Module 2 : Methodologies and Benefit Assessment of Medicines

  • Exploring various methodologies used in pharmacovigilance studies
  • Assessing the benefits and risks of medicines
  • Case studies illustrating benefit-risk assessment

Module 4 : Processing of Individual Case Safety Reports (ICSRs)

  • Step-by-step process of handling ICSRs
  • Signal detection and causality assessment
  • Quality control and validation of safety data

Module 6 : Pharmacovigilance Regulations and Risk Communication

  • Comparative analysis of pharmacovigilance regulations in the US, EU, and India
  • Effective risk communication strategies for healthcare professionals and patients
  • Case examples of successful risk communication campaigns

Module 8 : Aggregate Safety Reports and Risk Assessment

  • Creating aggregate safety reports (e.g., Periodic Safety Update Reports, PSURs)
  • Analyzing safety data trends over time
  • Risk assessment and mitigation planning
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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