Hoppa till sidans huvudinnehåll

Pharmaceutical and Medical Device Safety

A Study in Public and Private Regulation

Inbunden, Engelska, 2019

AvSonia Macleod,Sweta Chakraborty,UK) Macleod, Sonia (University of Oxford,Sonia MacLeod,Christopher Hodges

1 269 kr

Beställningsvara. Skickas inom 10-15 vardagar. Fri frakt för medlemmar vid köp för minst 249 kr.

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.

Produktinformation

  • Utgivningsdatum2019-02-21
  • Mått169 x 244 x 30 mm
  • Vikt712 g
  • FormatInbunden
  • SpråkEngelska
  • SerieCivil Justice Systems
  • Antal sidor320
  • FörlagBloomsbury Publishing PLC
  • ISBN9781509916696

Tillhör följande kategorier

Hoppa över listan

Mer från samma författare

Redress Schemes for Personal Injuries

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Christopher Hodges

Inbunden

1 579 kr

No-Fault Approaches in the NHS

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Sonia, MacLeod, Christopher Hodges

Inbunden

1 429 kr

No-Fault Approaches in the NHS

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Christopher Hodges

Häftad

699 kr

Hoppa över listan

Mer från samma serie

Ethical Business Practice and Regulation

Christopher Hodges, AreteWork LLP, Ruth Steinholtz, UK) Hodges, Professor Christopher (University of Oxford, Ruth (AreteWork LLP) Steinholtz, Aretework Llp, Christopher Hodges

Häftad

579 kr

Redress Schemes for Personal Injuries

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Christopher Hodges

Inbunden

1 579 kr

No-Fault Approaches in the NHS

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Sonia, MacLeod, Christopher Hodges

Inbunden

1 429 kr

Delivering Collective Redress

Christopher Hodges, Stefaan Voet, UK) Hodges, Professor Christopher (University of Oxford, Belgium) Voet, Professor Dr Stefaan (KU Leuven, Christopher Hodges

Inbunden

1 269 kr

Regulatory Delivery

Graham Russell MBE, Christopher Hodges, MBE Russell, Graham, UK) Hodges, Professor Christopher (University of Oxford, Graham Russell, Christopher Hodges

Inbunden

1 509 kr

Hoppa över listan

Du kanske också är intresserad av

No-Fault Approaches in the NHS

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Sonia, MacLeod, Christopher Hodges

Inbunden

1 429 kr

Redress Schemes for Personal Injuries

Sonia Macleod, Christopher Hodges, UK) Macleod, Sonia (University of Oxford, UK) Hodges, Professor Christopher (University of Oxford, Sonia MacLeod, Christopher Hodges

Inbunden

1 579 kr

Consumer ADR in Europe

Christopher Hodges, Iris Benöhr, Naomi Creutzfeldt, Christopher J S Hodges, Iris Benohr, Christopher Hodges

Inbunden

1 739 kr

Delivering Collective Redress

Christopher Hodges, Stefaan Voet, UK) Hodges, Professor Christopher (University of Oxford, Belgium) Voet, Professor Dr Stefaan (KU Leuven, Christopher Hodges

Inbunden

1 269 kr

Regulatory Delivery

Graham Russell MBE, Christopher Hodges, MBE Russell, Graham, UK) Hodges, Professor Christopher (University of Oxford, Graham Russell, Christopher Hodges

Inbunden

1 509 kr

Sustaining Access to Justice

Xandra Kramer, Masood Ahmed, Adriani Dori, María Carlota Ucín, the Netherlands) Kramer, Xandra (Erasmus University Rotterdam, UK) Ahmed, Masood (University of Leicester, the Netherlands) Dori, Adriani (Erasmus University Rotterdam, the Netherlands) Ucin, Maria Carlota (Erasmus University Rotterdam

Inbunden

1 509 kr