DRUG SAFETY PHYSICIAN TRAINING
Details
Outline
• Pharmacovigilance System and Practices Globally
• Pharmacovigilance Industry Regulations
• Regulatory reporting in Pharmacovigilance – Expedited and Aggregate
• Sources of ICSRs
• ICSR Processing
• Pharmacovigilance Safety Database
• MedDRA Coding
• WHO-DD Coding
• Causality Assessment
• Medical Review of ICSRs – Procedure and Practices
• Quality Management
• Aggregate Reports – Introduction and Overview
• Writing & Review of Aggregate Reports – Medical Assessments, Recommendations, and Conclusions
• RSI Updates and Procedures
• Signal Detection and Analysis
• Review of Pharmacovigilance technical and regulatory documents
• Handling Safety management plans
• Global Business Units and Functional Team Management and Communications with real time scenarios
• Medical interpretation and consistency to system documents, product labels, and adverse event case assessment etc.
Since its foundation in 2013, ACI is a leading Professional Training company located in Chandigarh, specializes in Pharmacovigilance training. ACI has been dedicated to create Pharmacovigilance Professionals through technical training program from a fresher to corporate level.
Our programs are customized as per the global regulatory and industry standards with a progressive approach to ensure that the Pharmacovigilance trainings are imparted with focus on creating Pharmacovigilance professionals.