Pharmacovigilance Masterclass: Global Compliance & Risk Mana
Published 7/2025
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 8.32 GB | Duration: 3h 33m
Master end-to-end PV processes, from signal detection to regulatory submissions, with EU, GCC, and FDA compliance insigh
What you'll learn
Understand the fundamentals and purpose of Pharmacovigilance in public health and regulatory frameworks.
Learn how to collect, assess, and report adverse drug reactions (ADRs) and individual case safety reports (ICSRs).
Identify signal detection techniques and apply risk management principles in real-world scenarios.
Develop and manage essential pharmacovigilance documents like PSURs, PBRERs, and the PSMF.
Requirements
No prior pharmacovigilance experience is needed. A basic understanding of healthcare or pharmaceutical terms is helpful but not required. All core concepts will be introduced clearly.
Description
This course is your ultimate guide to Pharmacovigilance (PV) and drug safety compliance. Designed for healthcare professionals, regulatory affairs specialists, pharmacists, and PV officers, the course provides in-depth, practical training aligned with international regulations and local practices.You will explore adverse event reporting, case management, PV systems, risk management plans, signal detection, CAPA processes, and audits. The course compares frameworks across the EU, GCC, and the US (FDA), and dives into local PV challenges and strategies in the Gulf region.Real-world case studies, quizzes, infographics, regulatory templates, and comprehensive video content ensure you gain actionable skills and knowledge. You'll also explore cutting-edge PV technologies like AI-based signal detection and learn how to respond to inspections and recalls effectively.Led by Othman Abdallah, a certified GDP, ISO, and PV consultant with 10+ years in regulatory affairs across Qatar, Bahrain, and the EU, this course ensures you'll walk away with confidence, certification, and globally recognized expertise. Whether you're enhancing your career or starting in PV, this program offers step-by-step learning, full support, practical tools, and real regulatory insights to help you succeed.We sincerely hope this course will be beneficial in supporting your career growth and professional success in the field of pharmacovigilance and global regulatory compliance.
This course is ideal for pharmacists, regulatory professionals, healthcare providers, QA/QC specialists, and life science graduates who want to start or advance their careers in Pharmacovigilance and drug safety monitoring.
Pharmacovigilance Masterclass: Global Compliance & Risk Mana
