About the course
Welcome to our Pharmacovigilance Mastery Course, designed to equip you with the essential knowledge and skills to excel in the critical field of drug safety monitoring. This program provides a thorough understanding of pharmacovigilance principles, regulatory requirements, and practical applications, ensuring you can effectively contribute to patient safety and regulatory compliance. Join us and become a sought-after professional in the dynamic and vital field of pharmacovigilance.
Course content
- Introduction to Pharmacovigilance:
- Understanding the history and evolution of pharmacovigilance.
- Exploring the importance of drug safety monitoring.
- Key Pharmacovigilance Concepts:
- Understanding adverse events (AEs) and adverse drug reactions (ADRs).
- Exploring signal detection and causality assessment.
- Regulatory Framework:
- Introduction to global pharmacovigilance regulations (e.g., ICH-GCP, GVP).
- Understanding the roles of regulatory authorities.
- Individual Case Safety Reports (ICSRs):
- Understanding the process of ICSR collection and reporting.
- Mastering the art of accurate and timely ICSR submissions.
- Aggregate Safety Data Analysis:
- Analyzing aggregate safety data for trends and patterns.
- Understanding the importance of signal detection.
- MedDRA Coding:
- Mastering the use of MedDRA for adverse event coding.
- Ensuring accurate and consistent coding practices.
- Signal Detection Methodologies:
- Understanding various signal detection methods and tools.
- Applying statistical techniques for signal detection.
- Risk Management Planning:
- Developing and implementing risk management plans.
- Understanding risk mitigation strategies.
- Benefit-Risk Assessment:
- Conducting benefit-risk assessments for medicinal products.
- Understanding the importance of balancing benefits and risks.
- Safety Data Exchange Agreements (SDEAs):
- Understanding the purpose and components of SDEAs.
- Managing safety data exchange with partners.
- Pharmacovigilance Audits and Inspections:
- Preparing for and conducting PV audits and inspections.
- Understanding regulatory expectations for audits.
- Corrective and Preventative Actions (CAPAs).
- Post-Marketing Surveillance:
- Understanding the importance of post-marketing safety monitoring.
- Implementing post-marketing safety studies.
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs):
- Preparing and submitting PSURs/PBRERs.
- Understanding the regulatory requirements for periodic reports.
- Risk Communication and Crisis Management:
- Developing effective risk communication strategies.
- Managing safety crises and public communication.
- Pharmacovigilance Databases:
- Understanding the functionality of PV databases.
- Using PV databases for data entry and analysis.
- Electronic Data Capture (EDC) Systems:
- Integrating EDC systems with PV databases.
- Ensuring data integrity and accuracy.
- Automation and AI in Pharmacovigilance.
- Real-World PV Scenarios:
- Analyzing and managing real-world PV cases.
- Applying learned concepts to practical situations.
- Case Studies and Role-Playing Exercises:
- Completing case studies and participating in role-playing exercises.
- Refining PV skills through practical application.
