Pharmacovigilance: A Practical Approach 2nd Edition

Capture the next level of drug-safety competence with Pharmacovigilance: A Practical Approach, 2nd Edition — a clear, contemporary guide by Thao Doan, Fabio Lievano, Linda Scarazzini, Charles Schubert, and Barbara Hendrickson. This authoritative resource is crafted for professionals navigating the complex world of drug safety across the United States, Europe, and global markets.

Engaging and immediately useful, the book breaks down core pharmacovigilance functions — from spontaneous reporting and signal detection to risk management and post-marketing surveillance — with real-world workflows, practical checklists, and regulatory context tied to FDA, EMA, ICH, and international best practices. Updated to reflect current expectations, it makes complex regulatory concepts accessible without sacrificing technical depth.

You’ll find step-by-step guidance on case processing, safety data lifecycle, benefit-risk assessment, and how to set up compliant pharmacovigilance systems in clinical and commercial settings. Practical examples and actionable templates help safety scientists, PV specialists, clinical researchers, and regulatory affairs teams apply principles immediately to their work.

Whether you’re building skills, refreshing procedures, or preparing for inspections and audits, this edition delivers the clarity and tools to reduce risk, streamline reporting, and strengthen patient safety programs worldwide. Clear language, focused chapters, and a professional layout make it a reliable desk reference and training companion.

Ready to advance your pharmacovigilance practice? Add Pharmacovigilance: A Practical Approach, 2nd Edition to your professional library and gain a practical, globally relevant roadmap to modern drug safety.

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.