Thinki corporate pharmacovigilance programmes are designed to provide comprehensive
yet cost effective training solutions to the client needs. All programmes have been
prepared in consultation with industry experts and cater to the live industry scenario
Programmes can be delivered at the client site or in an online mode Suitable for
beginners as well as mature PV companies
- Understanding pharmacovigilance systems
- Regulations in Pharmacovigilance
- This section would cover international regulations and applicable local regulations
as per client requirements
- Setting up a pharmacovigilance system
- Qualified Person for Pharmacovigilance (QPPV) and their importance
- Spontaneous case processing
- Receipt and handling of spontaneous reports including narrative writing
- Expeditable and non expeditable reports
- Medical Evaluation
- Quality Checks
- Electronic submissions
- Handling study reports
- Introduction to clinical studies and receipt of study reports
- Handling solicited and clinical study reports
- Narrative Writing
- Medical review and SUSARs (SUAs)
- Investigator’s Brochures and their significance
- Blinded clinical trials- PV considerations
- Literature search and review
- Regulations, Databases, review and case entry
- Aggregate reporting requirements
- Risk Benefit Assessment
- Aggregate Reports
- Roles and responsibilities
- Types of aggregate reports
- Content and format
- Quality control and distribution
- Signal detection, assessment and risk management plans
- General considerations
- Sources of signals
- Detection and assessment
- Risk assessment and minimization
- Guidance documents in Pharmacovigilance
- Types of guidance documents
- Importance and scope of SOPs and WIs
- Reference Safety Information
- Types of RSIs
- Role and Importance
- Review of and updating RSIs
- Pharmacovigilance Audits and Inspections
- Introduction and relevant guidance
- Audit preparations
- Audit findings and CAPA