Fundamentals Of Pharmacovigilance 1st/2017

Key Features :-

• Provides an insight into the conduct of practical pharmacovigilance in the pharmaceutical industry.
• Useful for the pharmacy/medical students and industry professionals who are keen to understand the pharmacovigilance domain.
•  The book offers a visually appealing design that makes reading of complex drug safety topics more efficient and interesting.
• Comprises simple illustrations & tables throughout to facilitate understanding, concept building and retention.
• Lucid presentation enables the readers to go through the topics at an accelerated pace.
• Includes numerous reader-friendly features such askey features and flowcharts.
• References at the end of each chapter enables the reader to refer to the sources of information and consider for further reading.

Discusses key topics of pharmacovigilance such as:

• History, origins and need for pharmacovigilance

• Key regulations in pharmacovigilance

• Individual case safety report management

• International organizations and regulatory authorities involved: USFDA, CDSCO, EMA, CIOMS, WHO, etc

• Aggregate reports (PSUR, PBRER, PADER)

• Signal management, Risk management

• Medical Dictionary for Regulatory Activities (MedDRA)

• Audits and inspections; Setting up of a Pharmacovigilance Centre and career options in pharmacovigilance