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Roman Grinblat, Sibylle Scholtz, Sophy Stock - Medizinprodukterecht im Wandel

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Roman Grinblat (ed.), Sibylle Scholtz (ed.), Sophy Stock (ed.)

Medizinprodukterecht im Wandel

2022

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Marc Oeben Die Verantwortliche Person nach der MDR. Neue Funktion für Regulatory-Compliance S. 251-272

„… : Regulatory ComplianceIn Art. 15 Abs. 3 der MDR ist der Aufgabenbereich der VerantwortlichenPerson umrissen …” „… . Die Verantwortliche Person ist damit die Schlüsselfunktion fürden Bereich „Regulatory Compliance“.Die …” „… Die Verantwortliche Person nach der MDR.Neue Funktion für Regulatory-ComplianceMarc OebenRund neun …”

Titelei/Inhaltsverzeichnis S. 1-18

„… LückerInhalt14Die Verantwortliche Person nach der MDR.Neue Funktion für Regulatory-Compliance 251Marc OebenDer …” „… Regulato-ry Affairs“ bzw. „Drug Regulatory Affairs“ sowie das mittlerweile in 17.Auflage stattfindende …” „… Medical Device Regulatory Affairs –Basic Course für die Praxis 35Konstantin von MartiusZwischen …”

Kirsten Plaßmann Der Hersteller unter MDR. Ein Wirtschaftsakteur mit vielen Gesichtern und zahlreichen Verpflichtungen S. 273-292

„… Feld.8.9.19 Qualified Person Responsible for Regulatory Compliance – QPRRC, im Sprach-gebrauch auch als …” „… . Die Medicines and Healthcare pro-ducts Regulatory Agency (MHRA), die medizinische Zulassungs- und …”

Jean L. Saliba Medizinprodukte unter dem Einfluss Künstlicher Intelligenz S. 487-506

„… Künstlicher Intelligenz - Schaffung einer Grundlage für Rechts-, Ethik- undCompliance-Fragen, MMR 2020, 440 …” „… Regelwerk – vorsichtigerer Natur zu sein. Man veröffentlichtebereits 2019 das „Proposed Regulatory Framework …” „… DrugAdministration (FDA), Proposed Regulatory Framework for Modifications to Arti-ficial Intelligence/Machine …”

doi.org/10.5771/9783748928133

Michael Friedewald, Alexander Roßnagel, Rahild Neuburger, Felix Bieker, Gerrit Hornung - Daten-Fairness in einer globalisierten Welt

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Michael Friedewald (ed.), Alexander Roßnagel (ed.), Rahild Neuburger (ed.), Felix Bieker (ed.), Gerrit Hornung (ed.)

Daten-Fairness in einer globalisierten Welt

Series: Privatheit und Selbstbestimmung in der digitalen Welt | Privacy and Self-Determination in the Digital World

Volume 2 2023

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Sebastian J. Kasper, Timo Hoffmann Targeting Reputation – Publication of Compliance as a Regulatory Concept in Comparative Data Protection Law S. 79-106

„… Targeting Reputation – Publication of Compliance as aRegulatory Concept in Comparative Data …” „… ’ subsequent compliance,and transparency about the agencies’ work can have their effects.24Second and Third …” „… structural elements for a typology to allow for futurecomparative assessments of regulatory concepts that …”

Marie-Louise Gächter „Data Free Flow with Trust“ - Auf der Suche nach dem Vertrauen S. 225-246

„… University Chicago Journal of Regulatory Compliance 2022, 1 (4).26 EuGH, Patrick Breyer gegen Bundesrepublik …” „… Regulatory Compliance (JRC), 8, S. 1-17.Zuiderveen Borgesius, Frederik (2017): The Breyer Case of the Court …” „… , Rz. 30-32.32 Vgl. etwa Reserve Bank of India, Statement on Developmental and RegulatoryPolicies vom 5 …”

Titelei/Inhaltsverzeichnis S. 1-12

„… 69Sebastian J. Kasper and Timo HoffmannTargeting Reputation – Publication of Compliance as a …” „… RegulatoryConcept in Comparative Data Protection Law 799Tom SchmidtDer Facebook-Beschluss des BGH – Datenschutz …”

doi.org/10.5771/9783748938743

Sergey Kabyshev, Luzius Mader - Regulatory Reforms - Implementation and Compliance

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Sergey Kabyshev (ed.), Luzius Mader (ed.)

Regulatory Reforms - Implementation and Compliance

Series: International Association of Legislation (IAL) / Deutsche Gesellschaft für Gesetzgebung (DGG)

Volume 17 2014

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Wim Voermans Motive-based enforcement S. 41-61

„… 1964-1968) Abstract What can public authorities do in order to promote regulatory compliance? This paper …” „… regulatory compliance. Compliant behaviour, or enforcement activities that reminds us of (or merely point out …” „… compliance theory. The first is the rational perspective (believing that regulatory addressees are rational …”

Titelei/Inhaltsverzeichnis S. 1-12

„… Regulatory Reforms Implementation and Compliance Luzius Mader/Sergey Kabyshev (eds.) Proceedings …” „… Mader/Sergey Kabyshev (eds.) Regulatory Reforms Implementation and Compliance Proceedings of the Tenth …” „… chosen for the 10th congress of the IAL ("Regulatory Reforms – Implementation and compliance") reflects …”

Congress Conclusions S. 345-348

„… Congress Conclusions Luzius Mader The concept of “regulatory reforms” is not a static, but an open …” „… prevailing at a certain moment in a specific national or international context. For some years, "regulatory …” „… of regulatory reforms: substantial changes in various policy fields, institutional and procedural …”

Alexey Avtonomov Urgent Legislation Drafting Technique Tasks in the Rule of Law Making in Contemporary Russia S. 62-80

„… : regulation impact assessment and compliance. Regulatory Impact Assessment It is well known that a regulatory …” „… law-making process in general and drafting work in particular need their own regulatory compliance, or simply …” „… first is legislation or regulation, by which I mean the enactment of laws and other regulatory acts on …”

Daniel Tsygankov Regulatory Impact Assessment in Russia S. 245-267

„… Panel 4 Institutional Reforms Regarding Legislative Procedures A Regulatory Impact Assessment …” „… Regulatory Impact Assessment in Russia Daniel Tsygankov Introduction According to normative definition given …” „… by one of the OECD Guidelines (2004), Regulatory Impact Assessment (RIA) is "supposed to help …”

Luzius Mader Opening Address S. 13-17

„… congress ("Regulatory Reforms – Implementation and Compliance") which particularly emphasizes the …” „… implementation of regulatory reforms and the compliance with or the enforcement of such reforms, the choice of …” „… all aware of the important and difficult challenges for regulatory reforms in Russia after the …”

Jean-Pierre Duprat Conclusions Panel 3 – Reform of Legal Regulation in Economics Conditions of a Better Balance between Necessary Adaptations to Changes and Interest of Operators for Legal Certainty S. 228-244

„… globalization induced a new dimension and intensified the reflexions on regulatory reforms, with an holistic …” „… document on regulatory reform in OECD countries, Paris (2003), 3. 3 In the context of the financial crisis …” „… : OECD – Recommendations of the Council on regulatory policy and governance, Paris (2012). 4 …”

Felix Uhlmann CAISSA S. 81-93

„… CAISSA Felix Uhlmann Introduction Why does regulation work? More generally: why do regulatory …” „… my opinion, the success or failure of regulatory reform can be explained in many cases by these six …” „… a detailed statement making it possible to appraise compliance with the principles of subsidiarity …”

Lorena Ossio Bustillos Latin America Perspective S. 143-157

„… regulatory complexity in social law and on how social legislation can be improved. This paper proposes that …” „… regulatory impact assessment meets the constitutional demands on the legislative process and how the …” „… regulatory impact assessment is able to increase the quality of social legislation.6 Finally, I aim to …”

Ulrich Karpen Regulatory Impact Assessment S. 268-272

„… Regulatory Impact Assessment Ulrich Karpen Evaluation of Legislation • The Constitution of the …” „… . • Subsidiarity and proportionality are quality standards as vested in European Treaties (Art. 5 TEU). Regulatory …” „… administrative bodies, debureaucratisation. 3. Regulatory Impact Assessment 269 • Effects on trust in continuity …”

Sergey Lipen Traditions of Studying Legislation Quality and Effectiveness in the Russian Legal Science of the Late XIX – Early XXI Centuries S. 329-334

„… regulatory impact in not absolutely new for the national legal scientific tradition; in one way or another …” „… regulatory impact assessment (in the European terminological tradition) have been reviewed within the …” „… , ideological, organizational and legal means of ensuring effectiveness of legal and regulatory acts, both …”

Timea Drinóczi, Miklós Kocsis Public Consultation – Theory and Hungarian Practice S. 303-324

„… developed approach towards better regulation.5 It indicates the joint interpretation of the regulatory and …” „… that may require more but smarter rules reflecting to the regulatory needs, previous experiences, best …” „… Communities, Communication from the Commission–Action plan “Simplifying and improving the regulatory …”

Yoel García Carrillo Corruption and Institutional Designs – Elements for the Design or Evaluation of an Anti-corruption Law S. 273-292

„… effective.4 3 To understand the scope of each regulatory system is necessary to differentiate the state …” „… organization of society. Corruption and institutional designs There is no society in the regulatory system that …” „… are running everyday politics in compliance with those, and that is where you place privileged …”

Yuriy Arzamasov Conclusions Panel 4 – Institutional Reforms Regarding Legislative Procedures – The extent of the prevalence of “low-level corruption” in Russia S. 335-344

„… regard, the RSPP last year conducted a comprehensive study on the improvement of regulatory compliance …” „… many factors leading to the adoption of regulatory legal acts of corruption. This is not following the …” „… .” Regulatory impact assessment In this regard, an important tool for the identification of legal monitoring of …”

Yuriy Tikhomirov Optimization of Legal Regulation and Methods of Design S. 25-40

„… Regulatory Reforms – Implementation and Compliance Optimization of Legal Regulation and Methods of …” „… regulatory impact assessment widely used in the member-countries of the Organization of Economic Cooperation …” „… (financial, analytical, reporting, etc.); • compliance of the state and municipal authorities with the …”

Natalia Putilo About Some Lawmaking Tendencies in Social Legislation of Russia S. 158-166

„… process, but it should be kept in mind that orientation solely on regulatory compliance in some cases …”

Olga Afanasieva The Efficiency of the Legislation on Transparency of the Public Power: A Social Context and the Quality of Laws S. 195-204

„… urgency in a context of the regulatory reforms occurring in the modern world in the last third of the past …” „… reduction to compliance with the law on access to information. Those national laws on access to official …”

doi.org/10.5771/9783845244228

Klaus Tiedemann, Ulrich Sieber, Helmut Satzger, Christoph Burchard, Dominik Brodowski - Die Verfassung moderner Strafrechtspflege

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Klaus Tiedemann (ed.), Ulrich Sieber (ed.), Helmut Satzger (ed.), Christoph Burchard (ed.), Dominik Brodowski (ed.)

Die Verfassung moderner Strafrechtspflege

Series: Studien zum Wirtschaftsstrafrecht - Neue Folge

Volume 10 2016

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William S. Laufer Compliance and Evidence: Glimpses of Optimism from a Perennial Pessimist S. 423-442

„… good compliance program from a less than adequate one was the penultimate unmet regulatory challenge—a …” „… are spending astronomical sums satisfying compliance and regulatory needs—with little to no evidence …” „… maintaining a regulatory equilibrium without good evidence of compliance, and fostering a science of …”

Ralf Kölbel Zu Herausforderungen für das regulatorische Strafrecht S. 379-400

„… einschließlich eines ausgeprägten selbst-regulatorischen Bereichs (Compliance-Organisation12). Im Hinblick auf …” „… Policies (Compliance-Programme, interne Richtlinien oder Kodizes, Unternehmensstrategien), die ebenfalls …” „… strafverfahrensrechtlichen Vorschriften sowie Compliance-Maßgaben zusammensetzt und auf der Kooperation von …”

Jesús-María Silva Sánchez “The Marriage of The Regulatory Process and The Criminal Law” – Eine verfassungsrechtlich kritische Einführung S. 411-422

„… “The Marriage of The Regulatory Process and The Criminal Law” – Eine verfassungsrechtlich kritische …” „… des Wohlfahrtsstaats bzw. des Leistungsstaats einhergeht. Das neue Staatsmodell – der Regulatory State …” „… Experten bestehende, unabhängige Regulierungsagenturen („independent regulatory agencies“) aus. Solche …”

Titelei/Inhaltsverzeichnis S. 1-12

„… of The Regulatory Process and The Criminal Law” – Eine verfassungsrechtlich kritische Einführung 411 …” „… Jesús-María Silva Sánchez Compliance and Evidence: Glimpses of Optimism from a Perennial Pessimist 423 William …”

Adán Nieto Martín A necessary triangle: the science of legislation, the constitutional control of criminal laws and experimental legislation S. 97-138

„… . The first is the law compliance that requires an appropriate implementation.40 But, in second place …” „… legislation and regulatory fitness,46 the objectives of which are to avoid the accumulation of obsolete laws …” „… : Regulatory Fitness and Performance Programme (RE- FIT): State of Play and Outlook, Brussels, 18.6.2014 COM …”

Dominik Brodowski Supranationale europäische Verwaltungssanktionen: Entwicklungslinien – Dimensionen des Strafrechts – Legitimität S. 139-180

„… mit Fußnoten versehenes Vortragsmanuskript „Regulatory Offences in the European Union“ mit Stand …” „… für compliance –, so entfaltet sie diese Funktion gegenüber Normtreuen bereits durch die Anordnung …”

doi.org/10.5771/9783845276953

Olga Batura, Bernd Holznagel, Jan Christopher Kalbhenn - Disinformation in Europe

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Olga Batura (ed.), Bernd Holznagel (ed.), Jan Christopher Kalbhenn (ed.)

Disinformation in Europe

Series: Schriften zum Medien- und Informationsrecht

Volume 77 2024

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Olga Batura Relationship between the DSA and the 2022 Code of Practice on Disinformation: Self-Regulation, Co-regulation or Regulation? S. 85-104

„… legal framework to understand the in‐terplay of the formerly self-regulatory tool (i.e. 2022 Code) and …” „… Code was the world-firstself-regulatory instrument to fight disinformation. The revision of the 2018 …” „… 2022 Code depend on whether itis a self-regulatory or a co-regulatory instrument. To determine this …”

Liudmyla Opryshko The right to receive reliable information in Ukraine S. 223-246

„… self-regulatory body for journalists, the Journalist EthicsCommission, whose main task is to promote compliance …” „… media regulator with broad regulatory and supervi‐sory powers;2) introduction of the institute of …” „… Council will be able to take into account theopinion of an expert panel established under a co-regulatory …”

Bernd Holznagel, Florian Flamme The role of the Federal Network Agency (Bundesnetzagentur) as Digital Services Coordinator in the fight against disinformation S. 177-194

„… data so that theycan assess compliance with the Regulation (Article 40 (1) and (2) DSA).This also means …” „… the Federal Cartel Of‐fice, Germany already has several regulatory authorities that have been pro‐12 …” „… relate to individual regulatory decisions.Bernd Holznagel and Florian Flamme184posed for the post of DSC …”

Judit Bayer Recalibration of the informational environment: the Regulation on political ads and its interplay with the DSA and the Code of Practice on Disinformation S. 105-134

„… regulatory measures to counter thenuanced challenges posed by this realm. A report about the compliance …” „… prevail‐ing regulatory norms. The escalating influence of online platforms on pub‐lic opinion and political …” „… scholarly exploration into the political and regulatory ramificationsof this campaigning approach.5 The …”

Jan Kalbhenn Fact-checkers and the new European media rules: The European Code of Standards for independent fact-checking organisations S. 135-152

„… media law,compliance with high methodological standards, and transparency in or‐ganisational and …” „… conclusion, the new regulatory structure is identified as anew media content law (section V.).II. The 2022 …” „… conditions. Conse‐quently, as a self-regulatory instrument, the 2022 Code of Practice on Dis‐information is …”

Olga Batura Policy recommendations to national governments S. 271-294

„… ; Helberger, Natali: The EU’s regulatory push against dis‐information: What happens if platforms refuse to …” „… introduced, as well as anobligation for social networks to label social bots.15Self-regulatory measures were …” „… adopted by certain platforms that felteither economic, social, or regulatory pressure to combat …”

Bernd Holznagel New ways to combat disinformation in Europe – codes of conduct and how they work S. 65-84

„… resilience-enhancing measuresto inform future regulatory and operational measures (Measure 29.3).Monitoring …” „… regulatory require‐ments and overarching objectives of the Digital Services Act (DSA) (Com‐mitment 44 …” „… 75 (4) DSA).In addition, compliance with the Code is also ensured by an independentreview. According to …”

Dariia Opryshko Regulation of media in the context of armed aggression S. 247-270

„… “On Media”). Non-compliance with these rules is considered asignificant violation and may entail the …” „… terminated.However, if the media bring their ownership structure and financing mech‐anisms into compliance with …” „… instruments (for instance, the con‐clusion of memoranda) and some regulatory provisions regarding …”

Colin Willeke Dissemination of Disinformation on Messenger Services: Shutting down Telegram or introducing a chat control? S. 153-176

„… classification of the communication as “private” or “public” is of fun‐damental importance for regulatory efforts …” „… Act).22 This generalregulation is supplemented by special media law provisions.233.3 Regulatory …” „… the dissemination of disinformation on Telegram, it isnot the regulatory framework that is lacking …”

Lorna Woods Approaches beyond the EU – Misinformation, disinformation and the Online Safety Bill in the UK S. 195-222

„… issues. OFCOMhas published its first consultation on the regulatory products associatedwith the illegal …” „… misinformation – is helpful for a regulatory regime. It is topic-neutraland potentially very broad. Moreover …” „… have accessto this, even where it might otherwise be voluntarily removed (i.e. fornon-compliance with …”

doi.org/10.5771/9783748948124

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