Pharmacovigilance Insight & Global Perspective

ISBN-13: 9781499721812 / Angielski / Miękka / 2014 / 144 str.

Neeru Agarwal

Opis

Pharmacovigilance Insight & Global Perspective is a step by step guide for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. It discussed about evolution of pharmacovigilance, ICH guidelines, Partners in Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, Global Perspective of Pharmacovigilance and Adverse Drug Reaction (ADR) Reporting, List of Technical Assistance providers in Pharmacovigilance, MedDRA, PV Glossary etc. The text provides exemplary coverage of all the relevant issues. The definitive book on the subject.