This “Qualified Pharmacovigilance Professional” training program aim to create Pharmacovigilance professionals by covering all the technical aspects of Pharmacovigilance job. The program includes 12 weeks of extensive training incorporate the unique technicalities and experience combined from our extensive team of industry professionals. The technical training on case processing with live experience on the Pharmacovigilance project gives the opportunity for candidates to excel in their Pharmacovigilance career.
TRAINING MODULES
- Introduction & History of Pharmacovigilance
- Pharmacovigilance complete Process
- Pharmacovigilance Terminologies
- Introduction & origin of Pharmacovigilance Guidelines
- Regulatory authorities – Worldwide
- International Conference on Harmonization (ICH)
- Guideline on good Pharmacovigilance practices (GVP)
- FDA 21 CFR Part 11
- ationale for Pharmacovigilance Monitoring
- Safety in the Lifecycle of Products
- PRE-MARKETING SAFETY ASSESSMENT
- POST-MARKETING SURVEILLANCE
- POST-MARKETING SURVEILLANCE METHODS
- ICSR PROCESSING
- Date of receipt
- Case validity
- Seriousness assessment
- Expectedness determination
- Case Follow-up Approaches
- Causality assessment
- Narrative writing
- Special Case Scenarios
- Case Nullification
- Record retention
- ICH E2B ICSR Transmission – Data Elements
- Introduction to safety databases
- Case Processing in E2B Compliance Safety Database
- MedDRA v20.0
- Scope, Introduction, Definition, Maintenance, Rationale
- MedDRA Applications
- Structure of MedDRA
- MedDRA Conventions
- Coding Guidelines
- MedDRA Important Medical Events (IME)
- MedDRA for Aggregate Data Output
- Change Request Information
- The MSSO Change Request Process
- MedDRA Version updates
- Expedited reporting
- Aggregate Reporting
- PSUR
- PBRERs
- ADCO
- DSURs
- Signal Detection & Assessments
TRAINING RECOGNIATION & ACCEPTANCE
- WHO Pharmacovigilance Guidelines
- International Conference on Harmonization
- Good Pharmacovigilance Practices Modules
TAKE AWAYS
- Training completion certificate
- Recommendation letter for candidates with good performance in training
