Pharmaceutical and Medical Device Safety 9781509916696

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Автор: Chakraborty Sweta
Название: Pharmaceutical and Medical Device Safety
ISBN: 9781509916696
Издательство: Bloomsbury Academic
Классификация:

Арбитраж, посредничество и альтернативное разрешение споров

Защита прав потребителей

ISBN-10: 1509916695
Обложка/Формат: Hardback
Страницы: 320
Вес: 0.71 кг.
Дата издания: 21.02.2019
Серия: Civil justice systems
Язык: English
Размер: 176 x 250 x 30
Читательская аудитория: Tertiary education (us: college)
Ключевые слова: Arbitration, mediation & alternative dispute resolution,Consumer protection law, LAW / Alternative Dispute Resolution,LAW / Arbitration, Negotiation, Mediation,LAW / Personal Injury
Подзаголовок: A study in public and private regulation
Рейтинг:
Поставляется из: Англии
Описание: This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the ‘private enforcement’ of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.

Pharmaceutical and Medical Device Safety, Chakraborty Sweta