Qualified Person Responsible for Pharmacovigilance (QPPV)
QPPV is required in Pharmacovigilance system as per the legal obligations in EU per GVP Module I which states that “all marketing authorization holders to have one qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company’s global pharmacovigilance system.” The QPPV is responsible for all Pharmacovigilance related activities like risk management including detection, assessment, understanding and communication of safety information. QPPV acts as a single point of contact for the Competent Authorities for inspections and other communication on a 24-hour basis.
QPPV Competency Framework:
• International standards for pharmacovigilance
Under this CERTIFIED QPPV Training Program, the participants will be trained on
• Good Pharmacovigilance Practice & Ethical Principles
• QPPV and EUDRAVIGILANCE Registration
• Regulatory and Legal Requirements in Pharmacovigilance
• Pharmacovigilance Operation Management
• Pharmacovigilance Risk Management and related activities
• Safety Monitoring & Signal Detection
• Pharmacovigilance IT system and Validation
• Pharmacovigilance Audits and Inspections
• Quality Control (QC) and Quality Assurance (QA)
• Pharmacovigilance System Documentations
• Pharmacovigilance System Metrics & KPIs Tracking
• Pharmacovigilance Training Management
• Pharmacovigilance Agreements
• Regulatory Reporting
• Documentation and Record Keeping
• Analytical skills and Decision Making
• Communication and Information Management
• Workload Management
TRAINING RECOGNIATION & ACCEPTANCE
• International Conference on Harmonization
• Good Pharmacovigilance Practices Modules
TAKE AWAYS
• Recommendation letter for candidates with good performance in training
