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
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