03935nam 22006015 450 991030023400332120200706162641.03-319-15805-810.1007/978-3-319-15805-1(CKB)3710000000402808(EBL)2094447(SSID)ssj0001501358(PQKBManifestationID)11830589(PQKBTitleCode)TC0001501358(PQKBWorkID)11524805(PQKB)10008941(DE-He213)978-3-319-15805-1(MiAaPQ)EBC2094447(PPN)185485588(EXLCZ)99371000000040280820150421d2015 u| 0engur|n|---|||||txtccrBenefit-Risk Assessment of Medicines[electronic resource] The Development and Application of a Universal Framework for Decision-Making and Effective Communication /by James Leong, Sam Salek, Stuart Walker1st ed. 2015.Cham :Springer International Publishing :Imprint: Adis,2015.1 online resource (326 p.)Description based upon print version of record.3-319-15804-X Includes bibliographical references.Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References.This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed, and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.PharmacyMedical researchDrug Safety and Pharmacovigilancehttps://scigraph.springernature.com/ontologies/product-market-codes/H69010Quality of Life Researchhttps://scigraph.springernature.com/ontologies/product-market-codes/H65000Pharmacy.Medical research.Drug Safety and Pharmacovigilance.Quality of Life Research.306353998610Leong Jamesauthttp://id.loc.gov/vocabulary/relators/aut789311Salek Samauthttp://id.loc.gov/vocabulary/relators/autWalker Stuartauthttp://id.loc.gov/vocabulary/relators/autBOOK9910300234003321Benefit-Risk Assessment of Medicines2512372UNINA