e-Book: BASIC COURSE OF PHARMACOVIGILANCE
The Complete Guide to Pharmacovigilance
This comprehensive guide provides a structured introduction to pharmacovigilance, covering everything from fundamental principles to advanced safety monitoring techniques. It is designed for professionals in the pharmaceutical industry, regulatory affairs, and clinical trials who seek a deeper understanding of drug safety, risk management, and compliance with international guidelines.
e-Book:
Basic course of Pharmacovigilance
Galyna Cordero
Supported by Bioscience Innova
Description:
Author: Galyna Cordero
Format: epub, azw3, mobi, pdf
Language: English
Print length: 452 pages
Publication date: February 10, 2025
€50
Key Topics:
✔ Introduction to Pharmacovigilance – History, importance, and core concepts
✔ Regulatory Frameworks & Compliance – Overview of global agencies, reporting requirements, and quality assurance
✔ Adverse Drug Reactions (ADRs) & Risk Assessment – Classification, prevention, and causality assessment
✔ Signal Detection & Management – Data mining techniques and real-world case studies
✔ Pharmacovigilance Systems & Emerging Technologies – AI in PV, global harmonization, and regulatory collaborationPerfect for:
✔ Pharmacovigilance professionals
✔ Regulatory specialists
✔ QPPVs & deputy QPPVs
✔ Clinical researchers
✔ Healthcare professionals
✔ Anyone looking to start a career in drug safetyWhat you will get:
✔ Deep understanding of GVP, ICSRs, signals
✔ Practical examples and cases
✔ Access to updated regulatory requirements
About the author:Galyna Cordero, MD is a recognized expert and educator in the field of drug safety and pharmacovigilance. She holds the position of Head of the Pharmacovigilance Department at JSC "Farmak" and serves as a Qualified Person for Pharmacovigilance (QPPV). Her extensive experience in the field allows her to conduct numerous webinars and workshops focusing on the intricacies of pharmacovigilance, particularly in regulatory compliance, risk management, signal detection, and the development of robust safety monitoring systems.As a lecturer and mentor, Dr. Cordero actively participates in international forums, congresses, conferences presenting on current trends in pharmacovigilance, crisis management in drug safety, and effective risk-benefit assessment strategies. She has conducted webinars that provide hands-on insights into topics such as signal detection, global regulatory requirements, and the role of technology in enhancing drug safety.Her role as a mentor extends beyond her webinars, where she supports the next generation of pharmacovigilance professionals through comprehensive training, case studies, and interactive discussions. Her sessions often highlight real-world applications of pharmacovigilance principles, helping participants prepare for regulatory inspections and the practical challenges of drug safety monitoring.
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