PHARMACOVIGILANCE TRAINING FOR PHARMACIST (PV)
Enhance Patient Safety by Mastering Adverse Event Monitoring and Regulatory Reporting Standards
Course Schedule
| Date | Venue | Fees |
|---|---|---|
| 05 – 06 Feb 2026 | Dubai, UAE | USD 1995 per delegate |
Course Introduction
Pharmacovigilance (PV) is a critical function in ensuring the safe use of medicines throughout their lifecycle. For pharmacists, whether in clinical, retail, hospital, or regulatory roles, understanding how to identify, report, and evaluate adverse drug reactions (ADRs) is key to patient safety and regulatory compliance.
This 2-day intensive training equips pharmacists with practical knowledge and tools to carry out effective pharmacovigilance activities. The course focuses on global PV standards, adverse event reporting procedures, risk management planning, and the role of pharmacists in safeguarding public health.
Course Objectives
By the end of this course, participants will be able to:
• Understand the principles and objectives of pharmacovigilance
• Recognize adverse drug reactions and collect complete safety data
• Submit ADR reports in compliance with national and international guidelines (e.g., ICH, WHO, EMA)
• Interpret signal detection and risk minimization strategies
• Contribute to the development of a robust pharmacovigilance system in their practice
• Comply with regulatory obligations as healthcare professionals
Key Benefits of Attending
• Gain the essential PV skills required for clinical and regulatory practice
• Strengthen your professional role in ensuring medicine safety and efficacy
• Learn reporting procedures and pharmacovigilance workflows
• Understand how to contribute to national safety databases and global PV networks
• Receive up-to-date knowledge on evolving pharmacovigilance regulations
Intended Audience
This program is designed for:
• Pharmacists in hospitals, retail, regulatory bodies, and pharmaceutical companies
• Pharmacy quality assurance and compliance officers
• Clinical pharmacists involved in patient care and ADR detection
• Medical affairs and drug safety personnel
• Pharmacists involved in drug utilization review and medication safety
Individual Benefits
Key competencies that will be developed include:
• Identification and classification of ADRs
• Adverse event documentation and regulatory reporting
• Knowledge of PV databases and national authority portals
• Risk communication and pharmacovigilance best practices
• Integration of PV responsibilities into pharmacy operations
Organization Benefits
Upon completing the training course, participants will demonstrate:
• Strengthened compliance with regulatory and safety standards
• Enhanced contribution to drug safety surveillance programs
• Better patient counseling on drug risks and safety
• More accurate and timely adverse event reporting
• Improved collaboration between pharmacy, clinical, and regulatory teams
Instructional Methdology
The course follows an interactive learning model:
• Lectures – Core PV concepts and pharmacist responsibilities
• Case Studies – Real-world ADRs and reporting workflows
• Workshops – Hands-on ADR form completion and documentation
• Peer Exchange – Discussion of challenges in PV implementation
• Tools – WHO-UMC tools, reporting templates, and assessment checklists
Course Outline
DETAILED 2-DAY COURSE OUTLINE
Training Hours: 7:30 AM – 3:30 PM
Daily Format: 3–4 Learning Modules | Coffee breaks: 09:30 & 11:15 | Lunch Buffet: 01:00 – 02:00
Day 1: Pharmacovigilance Foundations and Regulatory Reporting
- Module 1: Introduction to Pharmacovigilance (07:30 – 09:30)
• Historical context and global PV systems (WHO, EMA, FDA, ICH)
• Definitions: ADRs, serious events, unexpected reactions - Module 2: Role of Pharmacists in PV (09:45 – 11:15)
• Detection, documentation, and communication of safety concerns
• Ethical and legal responsibilities - Module 3: ADR Reporting Processes and Tools (11:30 – 01:00)
• National reporting systems and PV portals
• WHO-UMC reporting form, MedDRA coding basics - Module 4: Workshop – Completing an ADR Report (02:00 – 03:30)
• Hands-on practice using mock case studies
Day 2: Risk Management, Signal Detection, and Practical Integration
- Module 1: Signal Detection and Risk Minimization (07:30 – 09:30)
• Quantitative and qualitative signal detection
• Risk minimization strategies (education, labeling, REMS) - Module 2: PV in Hospital and Community Pharmacy Practice (09:45 – 11:15)
• Case-based discussion: polypharmacy, off-label use, vulnerable populations
• Integrating PV into daily workflow - Module 3: Communication and Patient Engagement (11:30 – 01:00)
• Counseling on ADRs and safe medicine use
• Educating patients and reporting via apps/portals - Module 4: Course Review & Assessment (02:00 – 03:30)
• Final quiz, participant presentations, and wrap-up
Certification
Participants will receive a Certificate of Completion in Pharmacovigilance for Pharmacists, recognizing their knowledge of drug safety reporting, PV compliance, and patient-centered pharmacovigilance practice.