Description
Paras Medical Publisher Fundamentals of Pharmacovigilance by Sumit Verma
Key - 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. - 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 as key features and flowcharts. - Discusses key topics of pharmacovigilance such -- History, origins and need for pharmacovigilance -- Key regulations in pharmacovigilance -- Individual case safety report management -- International organizations and regulatory authorities 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