Pharmacovigilance: A Practical Approach

Description:
Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

Features:

• Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologies
• Provides up-to-date coverage of hot topics in the field, including pharmacodynamic and safety precision medicine, immunogenicity, vaccine hesitancy and safety, genetic toxicology, and adverse events
• Contains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and more
• Offers new and expanded coverage of pharmacovigilance in early pre-clinical drug development through post-marketing surveillance, as well as a blueprint for training future pharmacovigilance professionals
• Includes real-world case studies to ensure content is relevant and applicable to everyday practice
• Discusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communication
• An digital version is included with purchase. The digital allows you to access all of the text, figures and references, with the ability to search, customize your content, make notes and highlights, and have content read aloud. Additional digital ancillary content may publish up to 6 weeks following the publication date

Table Of Contents:

SECTION 1 THE REGULATORY ENVIRONMENT AND THE PHARMACOVIGILANCE QUALITY SYSTEM
SECTION 2 PRECLINICAL SAFETY ASSESSMENT
SECTION 3 FIRST-IN-HUMAN TRIALS
SECTION 4 SAFETY ASSESSMENT IN CLINICAL TRIALS
SECTION 5 SIGNAL AND RISK MANAGEMENT
SECTION 6 ROLE OF EPIDEMIOLOGY AND REALWORLD EVIDENCE
SECTION 7 SPECIAL POPULATIONS AND SPECIAL TOPICS
SECTION 8 THE NEXT FRONTIER