Pharmacovigilance
Embark on a journey into pharmacovigilance, ensuring drug safety and patient well-being. Join our course to master the essentials of monitoring and reporting adverse drug reactions. What do you learn in the Pharmacovigilance Course? Adverse Drug Reactions (ADRs) Regulatory Framework …
Embark on a journey into pharmacovigilance, ensuring drug safety and patient well-being. Join our course to master the essentials of monitoring and reporting adverse drug reactions.
What do you learn in the Pharmacovigilance Course?
- Adverse Drug Reactions (ADRs)
- Regulatory Framework
- Pharmacovigilance Databases
- Pharmacovigilance Methods and Tools
- Clinical Trials and Drug Safety
- Post-Marketing Surveillance
- Risk Assessment and Benefit-Risk Analysis
- Pharmacovigilance Regulations
- Ethical and Legal Aspects
- Signal Detection and Management
- Pharmacovigilance in Special Populations
- Quality Assurance and Auditing
- Risk Communication
Who Should Pursue Pharmacovigilance Course?
- Pharmacists and Pharmacy Students
- Medical and Healthcare Professionals
- Pharmaceutical and Biotechnology Professionals
- Regulatory Affairs Specialists
- Clinical Research and Clinical Trials Professionals
- Drug Safety Officers
- Quality Assurance and Compliance Officers
- Healthcare Administrators and Managers
- Public Health and Epidemiology Professionals
- Research Scientists and Postgraduate Students
- Pharmaceutical Regulators and Inspectors
About this Certificate Course
A Pharmacovigilance course is a specialized training program designed for healthcare professionals, pharmaceutical experts, and regulatory affairs personnel. It focuses on the systematic monitoring and reporting of adverse drug reactions and potential safety issues related to pharmaceutical products. The curriculum typically includes topics such as regulatory compliance, signal detection, risk assessment, post-marketing surveillance, and ethical considerations. Pharmacovigilance courses are crucial for ensuring patient safety, adhering to regulatory requirements, and maintaining the quality and effectiveness of drugs in the market, making them essential for those involved in the pharmaceutical and healthcare sectors.
Course Outline
Our course instructor
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Why should you take a Pharmacovigilance Course?
Taking a Pharmacovigilance Course is vital for safeguarding patient well-being and ensuring the effectiveness of medications. It opens doors to rewarding careers in healthcare, pharmaceuticals, and regulatory affairs. Your knowledge can make a real difference in improving drug safety and public health.
Career Opportunities
Curriculum
- 4 Sections
- 55 Lessons
- 10 Weeks
- Module 1 – Fundamentals of Global Pharmacovigilance8
- 1.1Introduction to Drug Safety and PV
- 1.2Key PV Terminology (Side Effect, Drug Safety and Risk Terms)
- 1.3International Regulatory Requirements and Guidelines Overview
- 1.4Pharmacovigilance Quiz
- 1.5Regional Regulatory Requirements (FDA, EMA, Japan, China)
- 1.6Post-marketing Surveillance and Safety Management
- 1.7GVP – Pharmacovigilance Abbreviations
- 1.8Advanced Review of Adverse Event Reporting
- Module 2 – Advanced Review of Pharmacovigilance19
- 2.1Advanced Practice of Pharmacovigilance
- 2.2Pharmacovigilance Quiz
- 2.3Additional Encompassing and Confusing Terms in Pharmacovigilance
- 2.4MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)
- 2.5Pharmacovigilance Quiz
- 2.6Need for Pharmacovigilance
- 2.7The History of Pharmacovigilance
- 2.8Roles in Pharmacovigilance
- 2.9Pharmacovigilance Quiz
- 2.10Key Stakeholders in Pharmacovigilance
- 2.11Pharmacovigilance Quiz
- 2.12Post-marketing AE Processing and Reporting (ICSR, Case Processing, Narrative Writing & International Aggregate Reporting)
- 2.13Pharmacovigilance Quiz
- 2.14Signal Management (Detection, Validation, Prioritization and Action)
- 2.15Pharmacovigilance Quiz
- 2.16Risk Assessment, Plan and Management
- 2.17Pharmacovigilance Quiz
- 2.18Vaccine Surveillance – COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication and Case Studies)
- 2.19Post-authorization/ Post-marketing Regulations in Pharmacovigilance
- Module 3 – Argus Safety Database Certification7
- 3.1Argus Safety Database Certification Part 1
- 3.2Argus Safety Database Certification Part 2
- 3.3Argus Safety Database Certification Part 3
- 3.4Argus Safety Database Certification Part 4
- 3.5Argus Safety Database Certification Part 5
- 3.6Argus Safety Database Certification Part 6
- 3.7Oracle Argus Safety User Guide
- Module 4 – Resources21
- 4.1International Pharmacovigilance Initiatives and Guidelines – EMA
- 4.2DIA Safety and Pharmacovigilance Competencies
- 4.3WHO-ISoP Pharmacovigilance Resources
- 4.4E2E ‒ Pharmacovigilance Planning
- 4.5GVP XVI Addendum ‒ Educational Materials
- 4.6GVP Module I‒IV PV Systems, PSMF, Inspections & Audits
- 4.7GVP I – Pharmacovigilance Systems
- 4.8GVP VIII – Post-authorisation Safety Studies
- 4.9GVP III – Pharmacovigilance Inspections
- 4.10GVP IX – Methodological Aspects
- 4.11GVP V – Risk Management Systems
- 4.12GVP IX – Signal Management
- 4.13GVP VIII Addendum – Requirements, Recommendations
- 4.14GVP XV – Safety Communication
- 4.15GVP XVI – Risk Minimization Measures
- 4.16GVP II – Pharmacovigilance System Master File
- 4.17GVP VI – Duplicate Management
- 4.18GVP IV – Pharmacovigilance Audits
- 4.19GVP X – Additional Monitoring
- 4.20GVP VII – Periodic Safety Update Report
- 4.21GVP VI – Collection, Management and Submission of Reports
