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
