TY - GEN digital ID - 131712794 TI - Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication AU - Leong, James AU - Salek, Sam AU - Walker, Stuart PY - 2015 SN - 9783319158051 9783319158068 9783319158044 9783319367675 PB - Cham Springer International Publishing, Imprint: Adis DB - UniCat KW - Qualitative methods in social research KW - Sociology KW - Pharmacology. Therapy KW - Human medicine KW - sociologie KW - medisch onderzoek KW - farmacologie KW - levenskwaliteit KW - drugbeleid UR - https://www.unicat.be/uniCat?func=search&query=sysid:131712794 AB - 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. ER -