Zoekresultaat: 6 artikelen

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Jaar 2019 x
Article

Access_open Changes in the Medical Device’s Regulatory Framework and Its Impact on the Medical Device’s Industry: From the Medical Device Directives to the Medical Device Regulations

Tijdschrift Erasmus Law Review, Aflevering 2 2019
Trefwoorden Medical Device Directive, Medical Device Regulation, regulatory, European Union, reform, innovation, SPCs, policy
Auteurs Magali Contardi
SamenvattingAuteursinformatie

    Similar to pharmaceutical products, medical devices play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. From the patent law perspective both, pharmaceutical products and a medical apparatus, product or device can be patented if they meet the patentability requirements, which are novelty, inventiveness and entail industrial applicability. However, regulatory issues also impact on the whole cycle of the innovation. At a European level, enhancing competitiveness while ensuring public health and safety is one of the key objectives of the European Commission. This article undertakes literature review of the current and incoming regulatory framework governing medical devices with the aim of highlighting how these major changes would affect the industry at issue. The analysis is made in the framework of an on-going research work aimed to determine whether SPCs are needed for promoting innovation in the medical devices industry. A thorough analysis the aforementioned factors affecting medical device’s industry will allow the policymakers to understand the root cause of any optimal patent term and find appropriate solutions.


Magali Contardi
PhD candidate; Avvocato (Italian Attorney at Law).
Artikel

Access_open Criminaliteit en macht: een inleiding

Tijdschrift Tijdschrift over Cultuur & Criminaliteit, Aflevering 2 2019
Trefwoorden crimes of the powerful, white collar crime, hate crime, eco crime, ‘lawful but awful’
Auteurs Prof. dr. René van Swaaningen
SamenvattingAuteursinformatie

    Criminologists have by and large sought to explain crime by the deficiencies people may have. It took till the 1970s until the idea that crime can also be caused by structural power inequalities got an actual name in criminology: crimes of the powerful. Starting with the works of Willem Bonger and Edward Ross in the early 20th century, the author analyses how critical criminologists like Frank Pearce introduced the term ‘crimes of the powerful’ in the 1970s and how this concept was subsequently applied to gender- and racial inequalities, state crime, corruption et cetera, whilst pointing at the topical relevance of using a lens of ‘crimes of the powerful’ as a sensitising concept to analyse present-day problems, ranging from sexual abuse in the Roman Catholic church to the banking sector or indeed the expropriation of indigenous lands in the Amazon by soy-farmers and timber traders.


Prof. dr. René van Swaaningen
René van Swaaningen is hoogleraar criminologie en voorzitter van de sectie criminologie van de Erasmus Universiteit Rotterdam.
Artikel

Top-down and out?

Reassessing the labelling approach in the light of corporate deviance

Tijdschrift Tijdschrift over Cultuur & Criminaliteit, Aflevering 2 2019
Trefwoorden labelling, corporate crime, moral entrepreneurs, peer group, late modernity
Auteurs Anna Merz M.A.
SamenvattingAuteursinformatie

    Multi-national corporations are increasingly facing attention and disapproval by different actors, including authorities, public and (non-) commercial organizations. Digital globalization and especially social media as a low-cost, highly interactive and multidirectional platform shape a unique context for this rising attention. In the literature, much attention has been devoted to top-down approaches and strategies that corporations use to avoid stigmatization and sanctioning of their behaviour. Reactions to corporate harm are, however, seldom researched from a labelling perspective. As a result, corporations are not considered as objects towards whom labelling is targeted but rather as actors who hamper such processes and who, as moral entrepreneurs, influence which behaviour is labelled deviant. Based on theoretical analysis of literature and case studies, this article will discuss how the process of labelling has changed in light of the digitalized, late-modern society and consequently, how the process should be revisited to be applicable for corporate deviance. Given a diversification of moral entrepreneurs and increasingly dependency of labelling and meaning-making on the online sphere, two new forms of labelling are introduced that specifically target institutions; that is bottom-up and horizontal labelling.


Anna Merz M.A.
Anna Merz is promovendus aan de Sectie Criminologie van de Erasmus Universiteit Rotterdam.
Artikel

Tweede kansen, stigma’s en de praktijk van het civielrechtelijk bestuursverbod

Tijdschrift Maandblad voor Ondernemingsrecht, Aflevering 7 2019
Trefwoorden civielrechtelijk bestuursverbod, bestuursverbod, faillissementsfraude, curator, Openbaar Ministerie
Auteurs Mr. M. Neekilappillai en Mr. dr. N.T. Pham
SamenvattingAuteursinformatie

    Het civielrechtelijk bestuursverbod biedt de curator en het Openbaar Ministerie een instrument om faillissementsfraude effectiever te bestrijden. Op basis van rechtspraakanalyse en interviews met betrokken curatoren wordt betoogd dat het civielrechtelijk bestuursverbod geen geschikt instrument is voor het aanpakken van onkundige maar bonafide bestuurders.


Mr. M. Neekilappillai
Mr. M. Neekilappillai is als promovenda verbonden aan het Instituut voor Privaatrecht, afdeling Burgerlijk recht, van de Universiteit Leiden.

Mr. dr. N.T. Pham
Mr. dr. N.T. Pham is als universitair docent verbonden aan het Instituut voor Privaatrecht, afdeling Ondernemingsrecht, van de Universiteit Leiden.
Discussie

Access_open Europe Kidnapped

Spanish Voices on Citizenship and Exile

Tijdschrift Netherlands Journal of Legal Philosophy, Aflevering 1 2019
Trefwoorden migration, exile, citizenship, Europe, Spanish civil war
Auteurs Massimo La Torre
SamenvattingAuteursinformatie

    Exile and migration are once more central issues in the contemporary European predicament. This short article intends to discuss these questions elaborating on the ideas of two Spanish authors, a novelist, Max Aub, and a philosopher, María Zambrano, both marked by the tragic events of civil war and forced expatriation. Exile and migration in their existential perspective are meant as a prologue to the vindication of citizenship.


Massimo La Torre
Massimo La Torre is Professor of Legal Philosophy, Magna Græcia University of Catanzaro (Italy).
Artikel

Access_open ‘Lid van het Nederlandse matriciaat’

Interview met Abram de Swaan

Tijdschrift Tijdschrift over Cultuur & Criminaliteit, Aflevering 1 2019
Trefwoorden violence, compartimentalization, social theory
Auteurs Dr. Bas van Stokkom en Dr. mr. Marc Schuilenburg
SamenvattingAuteursinformatie

    In this article Bas van Stokkom and Marc Schuilenburg discuss work and life of the Dutch sociologist Abram de Swaan. The article is based on an interview the authors conducted with de Swaan as well as themes that de Swaan developed in his published work. The article discusses in particular themes such as violence and compartimentalization, the work of Norbert Elias, and public sociology.


Dr. Bas van Stokkom
Dr. Bas van Stokkom is senior onderzoeker bij de Vaksectie Strafrecht & Criminologie, Faculteit der Rechtsgeleerdheid, Radboud Universiteit Nijmegen.

Dr. mr. Marc Schuilenburg
Dr. mr. Marc Schuilenburg is universitair docent Strafrecht en Criminologie aan de Vrije Universiteit Amsterdam.
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