{"product_id":"benefit-risk-assessment-of-medicines-the-development-and-application-of-a-universal-framework-for-decision-making-and-effective-communication-von-james-leong-sam-salek-stuart-walker","title":"Benefit-Risk Assessment of Medicines","description":"\n                                \n                \u003cp\u003eThis 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.\u003c\/p\u003e\n                                \n                \u003cp\u003eOver 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.\u003c\/p\u003e\n                                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.\n            \n            \u003cdiv class=\"aw-variant-hidden-subtitle-div\" id=\"aw-variant-subtitle-9783319158044\"\u003e\u003ch3\u003eThe Development and Application of a Universal Framework for Decision-Making and Effective Communication\u003c\/h3\u003e\u003c\/div\u003e\u003cdiv class=\"aw-variant-hidden-subtitle-div\" id=\"aw-variant-subtitle-9783319367675\"\u003e\u003ch3\u003eThe Development and Application of a Universal Framework for Decision-Making and Effective Communication\u003c\/h3\u003e\u003c\/div\u003e","brand":"Libri","offers":[{"title":"Hardcover - 9783319158044","offer_id":40374468706397,"sku":"9783319158044","price":53.49,"currency_code":"EUR","in_stock":true},{"title":"Softcover - 9783319367675","offer_id":39420639641693,"sku":"9783319367675","price":53.49,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0940\/0622\/files\/e286ebbf-0512-4449-9c49-c814647d4711.jpg?v=1775105505","url":"https:\/\/shop.autorenwelt.de\/products\/benefit-risk-assessment-of-medicines-the-development-and-application-of-a-universal-framework-for-decision-making-and-effective-communication-von-james-leong-sam-salek-stuart-walker","provider":"Autorenwelt Shop","version":"1.0","type":"link"}