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.
Spis treści
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.
O autorze
James Leong, BSc Pharm Hons, MClin Pharm, Ph D, BCPS is a Board certified pharmacist and Head of Education at the Centre of Regulatory Excellence, Duke-NUS Graduate Medical School Singapore. His role focuses on identifying the educational needs for the various stakeholders involved in regulatory affairs in the Asia Pacific region and establishing educational roadmaps, priorities and deliverables. He received his Ph D in regulatory sciences from Cardiff University, UK.
Sam Salek Ph D RPh FFPM MRPSGB MCMS FESCP is Professor of Pharmacoepidemiology at the University of Hertfordshire, Hatfield, visiting Professor at the Estate of Hessen, Germany, and Director of the Institute for Medicines Development, Cardiff, UK. Professor Salek’s research focuses on mainly four areas including: development and application of patient-reported outcome measures; drug safety evaluation and pharmacovigilance; pharmacoeconomics and economic evaluation of healthcare; and pharmaceutical regulation and medicines development in the mature and emerging markets. He has published 19 books and 600 journal articles and abstracts. Professor Salek is member of five Editorial Boards and an active member of several societies.
Stuart Walker BSc, Ph D, MFPM FRSC FIBiol, FRCPath, is the Founder of the Centre for Medicines Research International, the Centre for Innovation in Regulatory Science and Professor of Pharmaceutical Medicine, University of Wales, Cardiff. During his research career in academia and industry, he has supervised many Ph D programmes in clinical development, regulatory policies, the Benefit/Risk Assessment of Medicines and Health Technology Assessment, co-authored 280 research papers and edited twenty-five books. He is frequently involved in the organisation of international meetings on key issues that concern the Regulatory Review of Medicines and has lectured extensively throughout Europe, the United States, the Asia-Pacific Region, Latin America and the Middle East.
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