Advanced Pharmacovigilance: Ensuring Drug Safety in Clinical Research

Aim

Short Courses Objectives

Short Courses Structure

Week 1: Introduction to Pharmacovigilance

• Overview of pharmacovigilance and its significance in clinical research

• Historical background and evolution of pharmacovigilance practices

Week 2: Pharmacovigilance Regulatory Framework

• International regulations and guidelines governing pharmacovigilance

• Role of regulatory authorities and their expectations for compliance

Week 3: Adverse Event Reporting and Signal Detection

• Adverse event classification, coding, and reporting requirements

• Signal detection methods and tools for identifying safety concerns

Week 4: Pharmacovigilance Databases and Systems

• Overview of pharmacovigilance databases (e.g., VigiBase) and their use

• Case management systems and electronic reporting platforms

Week 5: Risk Assessment and Benefit-Risk Evaluation

• Principles of risk assessment and benefit-risk evaluation in pharmacovigilance

• Decision-making processes for regulatory actions and risk management plans

Week 6: Safety Data Exchange and Collaboration

• International safety data exchange programs and initiatives

• Collaborative pharmacovigilance networks and their benefits

Week 7: Pharmacovigilance Audits and Inspections

• Preparing for pharmacovigilance audits and regulatory inspections

• Best practices for maintaining compliance and inspection readiness

Week 8: Pharmacovigilance in Clinical Trials

• Adverse event reporting in clinical trials and safety monitoring practices

• Investigator responsibilities and sponsor obligations in pharmacovigilance

Week 9: Pharmacovigilance in Post-Marketing Surveillance

• Post-marketing safety studies and real-world data collection
• Risk management strategies and pharmacovigilance in post-approval phase

Week 10: Signal Management and Risk Communication

• Signal management processes and assessment of emerging safety concerns

• Effective risk communication to healthcare professionals and the public

Week 11: Pharmacovigilance Quality Management

• Quality management systems and pharmacovigilance quality indicators

• Ensuring quality and continuous improvement in pharmacovigilance activities

Week 12: Pharmacovigilance Future Trends and Closing Remarks

• Emerging trends and technologies in pharmacovigilance

• Recapitulation of key concepts and closing remarks

Who Should Enrol?

Short Courses Outcomes