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
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
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