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Pharmacovigilance

This course provides a comprehensive understanding of pharmacovigilance, the science and system responsible for monitoring the safety, effectiveness, and benefit-risk profile of medicines. It covers the principles of adverse drug reaction (ADR) reporting, signal detection, quality management, pharmacovigilance program organization, reporting methods, communication strategies, and the role of healthcare professionals in ensuring patient safety. The course also introduces Good Pharmacovigilance Practices (GVP) and the operational framework of national pharmacovigilance programs.

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# Content
1 Introduction to Pharmacovigilance
2 Good Pharmacovigilance Practice (GVP)
3 Goals and Functions of Pharmacovigilance
4 Pharmacovigilance Documentation
5 Adverse Drug Reaction (ADR) Reporting
6 Resources and Stakeholders
7 Pharmacovigilance Reporting Methods
8 Organization of Pharmacovigilance Programs
9 Communication in Pharmacovigilance
10 Achievements and Future Development
# Outcomes
• Define pharmacovigilance and explain its significance in healthcare.
• Identify adverse drug reactions (ADRs) and understand the reporting process.
• Evaluate the benefit-risk balance of medicinal products.
• Perform basic pharmacovigilance activities following Good Pharmacovigilance Practices.
• Select appropriate reporting methods for pharmacovigilance cases.
• Interpret the functions of pharmacovigilance committees and review panels.
• Promote effective communication of medicine safety information to stakeholders.
• Support continuous improvement of pharmacovigilance systems within healthcare and pharmaceutical organizations
# Participants
1
• Pharmacists
2
• Physicians and Clinicians
3
• Nurses
4
• Quality Assurance (QA) Professionals
5
• Quality Control (QC) Personnel
6
• Regulatory Affairs Professionals
7
• Drug Safety and Pharmacovigilance Officers
8
• Clinical Research Associates
9
• Pharmaceutical Industry Professionals
10
• Hospital and Healthcare Administrators
11
• Medical Affairs Personnel
12
• Students and graduates in pharmacy, medicine, and life sciences