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
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