Pharmacy & Drugs
Highlights sur Pharmacovigilance
Description
Pharmacovigilance et all drug safety issues are pertinent pour all those whose life is touched by medical intervention(s). Thus le safety alarms et chaos that resulted recurrently, commencing from thalidomide disaster, led to many painstaking initiatives by le regulatory bodies. It has been an attempt by le International Conference sur Harmonization (ICH), Monde Health Organization (WHO) et Uppsala Monitoring Committee (UMC) to make le best de amendments related to progress en le field de Pharmacovigilance. Le book discusses about Council pour International Organizations de Medical Sciences (CIOMS), a WHO initiative which focuses sur various activities such as expedited reporting, electronic reporting, periodic safety updates, Core clinical Safety information (CCSI), Benefit risk evaluation et Good case management et reporting practices. For le pharmaceutical industry, pharmacovigilance is le post-marketing surveillance de le safety de authorized commercialised medicinal products during their life sur le market. Safety et risk management systems need to be strategically integrated alongside business processes. Approche which not only delivers but also controls le overall risk management should be existent avec all companies including specifically small et midsize startup companies. Further le distinction between an Adverse event et Adverse reaction has been clearly described, following which significance pertaining to causality assessment has also been emphasized. Le intrinsic properties de le drug et le rarity avec which a drug gives rise to an adverse reaction has given rise to vast thought provoking discussions by regulators, pharmaceutical companies, pharmacovigilators to arrive at concrete steps that may lead to recognizing safety signals which can aid en minimizing risks. Accordingly signal detection which form yet another key important aspect de pharmacovigilance has been comprehensively discussed. Le impact de adverse reactions show a discrepancy to a larger extent sur special population such as geriatrics, pediatrics, pregnant women, thus this topic has been meticulously dealt within this book. Many more subject matters et issues applicable to drug safety has been penned down pour our readers. Transforming pharmaceutical and/or biotechnological business avec tangible innovations et transformational outcomes is le key to success. In a nutshell, optimizing PV processes is quintessential to keep le business growing et healthy. This book finds multidisciplinary usage pour wide-range de readers such as: regulators, pharmaceutical et biotech companies, pharmacovigilators, medical et paramedical professionals. We wish all de you contented reading.
Table des matières
Foreword; Preface; Acknowledgements; À propos de le Authors; Introduction à Pharmacovigilance; Méthodes en Pharmacovigilance; Adverse Drug Reactions; Causality Assessment; Medical Dictionary pour Regulatory Activities (MedDRA); Signal Detection; Special Cases; Special Population; Periodic Safety Update Reports (PSURs) et Serious; Unexpected Adverse Drug Reaction (SUSARs);