Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
Access to non-summary clinical trial data for research purposes under EU law / / Daria Kim
| Access to non-summary clinical trial data for research purposes under EU law / / Daria Kim |
| Autore | Kim Daria |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2021] |
| Descrizione fisica | 1 online resource (310 pages) |
| Disciplina | 342.240662 |
| Collana | Munich studies on innovation and competition |
| Soggetto topico |
Freedom of information - European Union countries
Clinical trials Freedom of information |
| ISBN | 3-030-86778-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- Preface -- Acknowledgements -- Contents -- Abbreviations -- Chapter 1: Introduction -- References -- Part I: Setting the Scene -- Chapter 2: The Context and the Problem -- 2.1 Clinical Trials: General Aspects -- 2.1.1 Basic Definitions -- 2.1.2 The Social Value of Clinical Trials -- 2.1.3 Clinical Trials in the Regulatory Context -- 2.1.3.1 Clinical Trial Approval -- 2.1.3.2 Drug Marketing Authorisation -- 2.1.4 Clinical Trials as a Part of Industry RandD -- 2.2 The Debate Over Access to Clinical Trial Data -- 2.2.1 Concerns Related to Restricted Access to Clinical Trial Data -- 2.2.2 Transparency Issues -- 2.2.3 Levels of Transparency in Clinical Trials -- 2.2.3.1 Trial Registration -- 2.2.3.2 Reporting and Publication of Trial Results -- 2.2.3.3 Accessibility of Non-Summary Data -- 2.2.4 International Norm-Setting Initiatives Promoting Transparency in Clinical Research -- 2.2.5 Institutional Developments -- 2.2.5.1 Editorial Campaign -- 2.2.5.2 Funding Institutions -- 2.2.6 Access to Data as a Digital Resource in the Context of Data-Driven Innovation -- 2.2.6.1 The Promises of `Big Data´ -- 2.2.6.2 Legal and Policy Debate Concerning `Ownership´ of Sensor-Generated Data -- 2.2.6.3 `Big Data´ Analysis in Public Healthcare and Drug RandD -- 2.2.6.4 Data-Sharing Policies and Practices Adopted by the Pharmaceutical Industry -- 2.3 Diversity of Policy Approaches and Academic Views -- 2.3.1 The Controversy Over Disclosure of Non-Summary Clinical Trial Data in the EU -- 2.3.1.1 Investigations of the European Ombudsman -- 2.3.1.2 The EMA Transparency Policies -- 2.3.1.3 Evolving Case Law of the CJEU on Clinical Trial Data Disclosure -- 2.3.2 Policy Approaches in Other Jurisdictions -- 2.3.3 Academic Discourse -- 2.3.3.1 General Medical Literature -- 2.3.3.2 Legal Discourse on Access to Clinical Trial Data.
Removing Financial Ties with the Industry -- Disclosure as a quid pro quo for Data Exclusivity Protection -- Amending the Freedom of Information Legislation -- 2.3.3.3 Comparative and International Law Perspectives -- 2.4 The Present Study Against the Background of Policy and Legal Discourse -- References -- Chapter 3: Secondary Analysis of Individual Patient-Level Clinical Trial Data: A Primer -- 3.1 Clinical Trial Data -- 3.1.1 Definitions and General Aspects -- 3.1.2 The Types of Clinical Trial Data -- 3.1.3 The `Life-Cycle´ of Clinical Trial Data -- 3.2 Clinical Trial Data as a Source of Medical Knowledge -- 3.2.1 Clinical Trial Data as a Source of Scientific Knowledge -- 3.2.2 The Types of Data Analyses -- 3.2.2.1 Primary and Secondary Data Analyses -- 3.2.2.2 Confirmatory Secondary Data Analysis -- 3.2.2.3 Exploratory Secondary Analysis -- 3.2.2.4 Subgroup Data Analysis -- 3.2.2.5 Interaction Analysis -- 3.2.2.6 Predictive Models and Prognostic Variables -- 3.2.2.7 Meta-analysis and Systematic Reviews -- 3.2.3 Fields of Research -- 3.2.3.1 Pharmacology -- 3.2.3.2 Epidemiology, Clinical Epidemiology and Pharmacoepidemiology -- 3.2.3.3 Aetiology, Pathology and Pathophysiology -- 3.2.3.4 Research on Biomarkers -- 3.3 Exploratory Analysis of Clinical Trial Data in Drug RandD -- 3.3.1 `Data-Driven´ Drug RandD -- 3.3.2 The Application of Data Analytics in Drug Discovery -- 3.3.3 Secondary IPD Analysis in Planning and Design of New Trials -- 3.3.4 Secondary Analysis of Data from Unsuccessful Trials -- 3.4 Secondary Data Analysis by Drug Regulators -- 3.4.1 Advancing Regulatory Science -- 3.4.2 Extrapolation -- 3.5 Conclusion on Chapter 3 -- References -- Part II: Analysis De Lege Lata -- Chapter 4: Legal Sources of Control Over and Access to Clinical Trial Data Under the EU Applicable Framework. 4.1 The EU Legal and Regulatory Framework Applicable to Clinical Trial Data -- 4.1.1 Relevant Provisions Under Primary Law -- 4.1.2 Relevant Sources of Secondary Law -- 4.1.2.1 The EU Regulation on Clinical Trials -- General Aspects -- Data Reliability and Robustness -- The EU Database for Clinical Trial Data -- 4.1.2.2 The EU Drug Authorisation Regulation -- 4.1.2.3 The EMA´s Guidance on the Implementation of the Publication Policy -- 4.2 Legal Sources of Control of Trial Sponsors Over Individual Patient-Level Clinical Trial Data -- 4.2.1 Do Drug Sponsors `Own´ Clinical Trial Data? -- 4.2.1.1 Competing Claims of Data Ownership -- 4.2.1.2 De facto Control But Not de jure Ownership of IPD -- The Obligation to Protect Data Against Unauthorised Access as the Source of de facto Exclusive Control -- No Property Rights in IPD as Personal Data -- No in rem Rights in Sensor-Generated Data -- Data Fixed and Stored in a Material Medium -- 4.2.2 The Applicability of the EU Trade Secrets Directive to Non-summary Clinical Trial Data -- 4.2.2.1 The Legal Definition of a Trade Secret -- 4.2.2.2 The Applicability of Trade Secret Protection to CSRs -- 4.2.2.3 The Applicability of Trade Secret Protection to IPD -- The Secrecy Requirement -- The Requirement of Commercial Value Due to Secrecy -- The Requirement of Protection Measures to Preserve Secrecy -- 4.2.3 The Applicability of the EU Database Directive to IPD -- 4.2.3.1 IPD from an Individual Trial -- 4.2.3.2 The Applicability of the Copyright Type of Database Protection -- 4.2.3.3 The Applicability of the sui generis Database Right -- 4.2.4 Data Exclusivity Protection -- 4.2.4.1 The Abridged Procedure for Drug Marketing Authorisation -- 4.2.4.2 Data Exclusivity as a Temporary Derogation from the Abridged Procedure -- 4.2.4.3 The Nature and Scope of Test Data Exclusivity Protection. 4.2.5 Contractually Obtained Exclusive Control -- 4.2.5.1 Contractual Practice Related to Obtaining Clinical Trial Data -- 4.2.5.2 Implications of Contractually Defined `Exclusive Property´ in Trial Data -- 4.3 Access Regimes Applicable to Clinical Trial Data -- 4.3.1 Regulatory Requirements for Clinical Trial Data Disclosure -- 4.3.1.1 What Data Is (Supposed to Be) in the Public Domain? -- 4.3.1.2 Uncertainty Regarding the Definition of CCI -- 4.3.2 The Relevance of the Right of Access to Personal Data -- 4.3.3 Access to IPD Under the Right of Access to Documents -- 4.3.3.1 The Right of Access to Documents Held by Public Authorities -- 4.3.3.2 The Exception for Protection of Commercial Interests in the Case of Clinical Trial Data -- The Exception for Protection of Commercial Interests -- The Existence of the General Presumption of Confidentiality for CSRs -- 4.3.3.3 Implications for the Publication of Clinical Trial Data in the EU Database -- 4.3.3.4 Limitations of the Right of Access to Documents as an Instrument of Access to IPD for Research Purposes -- 4.3.4 Competition Law as an (Unsuitable) Instrument of Access to IPD -- 4.3.4.1 Access to IPD as a Hypothetical Case on a Refusal to Deal -- 4.3.4.2 The Assessment of a Refusal to Grant Access to IPD for Exploratory Analysis Under Article 102 of the TFEU -- The Standard of Intervention Where Access to Information or Data Is Refused -- The Dominance of the IPD Holder -- IPD Indispensability for Exercising an Activity on a Neighbouring Market -- The Exclusion of Effective Competition in a Neighbouring Market -- The Appearance of a New Product for Which There Is Potential Consumer Demand -- The Objective Justification of a Refusal -- 4.3.4.3 Conclusion on the Application of Competition Law -- 4.4 Conclusion on Chapter 4 -- References. Chapter 5: Implications of IPD Disclosure for Statutory Innovation Incentives -- 5.1 The Impediment-to-Innovation-Incentives Claim -- 5.1.1 Arguments Submitted During the EMA Public Consultation -- 5.1.2 Arguments Raised Before the CJEU -- 5.1.3 Restrictive Provisions Under the Industry Data-Sharing Policies -- 5.2 Dissecting the Claim -- 5.2.1 Innovation -- 5.2.2 Innovation Incentives -- 5.2.3 The Problem of Appropriability in Drug Innovation -- 5.2.4 Innovation Incentives -- 5.2.4.1 Patents and SPCs -- 5.2.4.2 Incentive Instruments Under the Sector Legislation -- 5.3 Implications of IPD Disclosure for Patent Protection -- 5.3.1 Concerns of Drug Companies -- 5.3.2 Implications of Non-summary Clinical Trial Data Disclosure for Patentability -- 5.3.2.1 Novelty -- 5.3.2.2 Inventive Step -- 5.3.2.3 Summary of Implications of Data Disclosure for Patentability -- 5.3.2.4 Implications of Disclosure for SPC Protection -- 5.4 Implications of IPD Disclosure for Sector-Specific Incentives -- 5.4.1 Implications of Data Disclosure for Data Exclusivity Protection in the EU -- 5.4.1.1 Concerns Regarding the Circumvention of Data Exclusivity Protection -- 5.4.1.2 Implications of Data Disclosure for Test Data Exclusivity Protection in the EU -- 5.4.1.3 The Risk of Misusing Disclosed Data Outside of the EU -- 5.4.2 Implications of Data Disclosure for Orphan Drug Exclusivity -- 5.5 Conclusion on Chapter 5 -- References -- Part III: Analysis De Lege Ferenda: Exclusively Controlled or Readily Accessible? -- Chapter 6: Defining the Intervention Logic of Access-To-Data Measures: A Problem Analysis -- 6.1 General Principles of Regulatory Intervention -- 6.1.1 Regulatory Intervention as an Exception -- 6.1.2 The Grounds for Policy Intervention -- 6.1.3 Social Welfare as a Normative Benchmark -- 6.1.4 Necessity and Proportionality as the Guiding Principles. 6.2 The European Commission´s Methodology for Problem Analysis. |
| Record Nr. | UNINA-9910506380003321 |
Kim Daria
|
||
| Cham, Switzerland : , : Springer, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Derecho a la información : crisis del sistema político transparencia de los poderes públicos / / Fernando Condesso
| Derecho a la información : crisis del sistema político transparencia de los poderes públicos / / Fernando Condesso |
| Autore | Condesso Fernando |
| Pubbl/distr/stampa | Madrid : , : Dykinson, , 2011 |
| Descrizione fisica | 1 online resource (258 p.) |
| Disciplina | 342.240662 |
| Soggetto topico |
Freedom of information - European Union countries
Transparency in government - European Union countries Libertad de información Gobierno |
| ISBN |
84-15-45516-X
84-15455-16-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910671394003321 |
|
Condesso Fernando
|
||
| Madrid : , : Dykinson, , 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Garantía administrativa de los derechos del interesado en materia de protección de datos personales / / Juan Francisco Rodríguez Ayuso
| Garantía administrativa de los derechos del interesado en materia de protección de datos personales / / Juan Francisco Rodríguez Ayuso |
| Autore | Rodríguez Ayuso Juan Francisco |
| Pubbl/distr/stampa | Barcelona : , : J M BOSCH EDITOR, , 2021 |
| Descrizione fisica | 1 online resource (242 pages) |
| Disciplina | 342.240662 |
| Collana | Colección monografías. Protección de datos personales |
| Soggetto topico |
Data protection - European Union countries
Protección de la información - Derecho Derecho a la vida privada Protección de datos |
| Soggetto genere / forma | Libros electronicos. |
| ISBN | 84-122999-7-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Nota di contenuto | Página legal -- ndice -- Abreviaturas -- Introducción -- Capítulo I -- I. Derecho de acceso -- II. Derecho de rectificación -- III. Derecho de supresión -- IV. Derecho de oposición -- Cpítulo II -- I. Derecho a la limitación -- II. Derecho a la portabilidad -- III. Derecho a no ser objeto de decisiones -- IV. El debilitamiento de los derechos -- V. Las limitaciones en el ejercicio -- VI. El derecho del interesado -- VII. El derecho del interesado al recurso -- Capítulo III -- I. Introducción -- II. Derecho a la neutralidad de la red -- III. Derecho a la seguridad -- IV. Derecho a la educación -- V. Protección de los menores -- VI. Derecho a la rectificación -- VII. Derecho a la actualización -- VIII. Derechos a la intimidad y uso de dispositivos -- IX. Derecho a la desconexión digital -- X. Derechos digitales -- XII. Derecho de portabilidad en servicios -- XIII. Derecho al testamento -- XIV. Políticas de impulso de los derechos -- Bibliografía. |
| Record Nr. | UNINA-9910672343603321 |
|
Rodríguez Ayuso Juan Francisco
|
||
| Barcelona : , : J M BOSCH EDITOR, , 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information rights and obligations : a challenge for party autonomy and transactional fairness / / edited by Geraint Howells, Andre Janssen, Reiner Schulze
| Information rights and obligations : a challenge for party autonomy and transactional fairness / / edited by Geraint Howells, Andre Janssen, Reiner Schulze |
| Pubbl/distr/stampa | London : , : Routledge, , 2016 |
| Descrizione fisica | 1 online resource (246 pages) |
| Disciplina | 342.240662 |
| Altri autori (Persone) |
HowellsGeraint G
JanssenAndre <1972-> SchulzeReiner |
| Collana | Markets and the Law |
| Soggetto topico |
Liberty of contract - European Union countries
Contracts - European Union countries Disclosure of information - Law and legislation - European Union countries |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-138-25712-5
1-315-25228-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Autonomy and fairness : the case of public statements / Chris Willett -- 2. The strategy and the harmonization process within the European legal system : party autonomy and information requirements / Paola Gozzo -- 3. Evolution of party autonomy in a legal system under transformation : recent developments in Poland under special consideration of the Package Travel Directive / Katarzyna Michaowska -- 4. From truth in lending to responsible lending / lain Ramsay -- 5. EC directives for self-employed commercial agents and on time-sharing : apples, oranges and the core of the information overload problem / Bettina Wendlandt -- 6. Information requirements in the E-Commerce Directive and the proposed directive on unfair commercial practices / Annette Nordhausen -- 7. Contractual disclosure and remedies under the Unfair Contract Terms Directive / Edoardo Ferrante -- 8. Information disclosure about the quality of goods : duty or encouragement? / Christian Twigg-Flesner -- 9. Information and product liability : a game of Russian roulette? / Geraint Howells -- 10. Duties to inform versus party autonomy : reversing the paradigm (from free consent to informed consent)? : a comparative account of French and English law / Ruth Sefton-Green -- 11. The information requirements in the principles of European private law 'long-term commercial contracts : commercial agency, distribution, franchise' : a model for a European civil code? / Andre Janssen. |
| Record Nr. | UNINA-9910466004403321 |
| London : , : Routledge, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information rights and obligations : a challenge for party autonomy and transactional fairness / / edited by Geraint Howells, Andre Janssen, Reiner Schulze
| Information rights and obligations : a challenge for party autonomy and transactional fairness / / edited by Geraint Howells, Andre Janssen, Reiner Schulze |
| Pubbl/distr/stampa | London : , : Routledge, , 2016 |
| Descrizione fisica | 1 online resource (246 pages) |
| Disciplina | 342.240662 |
| Altri autori (Persone) |
HowellsGeraint G
JanssenAndre <1972-> SchulzeReiner |
| Collana | Markets and the Law |
| Soggetto topico |
Liberty of contract - European Union countries
Contracts - European Union countries Disclosure of information - Law and legislation - European Union countries |
| ISBN |
1-351-92758-2
1-138-25712-5 1-315-25228-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Autonomy and fairness : the case of public statements / Chris Willett -- 2. The strategy and the harmonization process within the European legal system : party autonomy and information requirements / Paola Gozzo -- 3. Evolution of party autonomy in a legal system under transformation : recent developments in Poland under special consideration of the Package Travel Directive / Katarzyna Michaowska -- 4. From truth in lending to responsible lending / lain Ramsay -- 5. EC directives for self-employed commercial agents and on time-sharing : apples, oranges and the core of the information overload problem / Bettina Wendlandt -- 6. Information requirements in the E-Commerce Directive and the proposed directive on unfair commercial practices / Annette Nordhausen -- 7. Contractual disclosure and remedies under the Unfair Contract Terms Directive / Edoardo Ferrante -- 8. Information disclosure about the quality of goods : duty or encouragement? / Christian Twigg-Flesner -- 9. Information and product liability : a game of Russian roulette? / Geraint Howells -- 10. Duties to inform versus party autonomy : reversing the paradigm (from free consent to informed consent)? : a comparative account of French and English law / Ruth Sefton-Green -- 11. The information requirements in the principles of European private law 'long-term commercial contracts : commercial agency, distribution, franchise' : a model for a European civil code? / Andre Janssen. |
| Record Nr. | UNINA-9910792772603321 |
| London : , : Routledge, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information rights and obligations : a challenge for party autonomy and transactional fairness / / edited by Geraint Howells, Andre Janssen, Reiner Schulze
| Information rights and obligations : a challenge for party autonomy and transactional fairness / / edited by Geraint Howells, Andre Janssen, Reiner Schulze |
| Pubbl/distr/stampa | London : , : Routledge, , 2016 |
| Descrizione fisica | 1 online resource (246 pages) |
| Disciplina | 342.240662 |
| Altri autori (Persone) |
HowellsGeraint G
JanssenAndre <1972-> SchulzeReiner |
| Collana | Markets and the Law |
| Soggetto topico |
Liberty of contract - European Union countries
Contracts - European Union countries Disclosure of information - Law and legislation - European Union countries |
| ISBN |
1-351-92758-2
1-138-25712-5 1-315-25228-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Autonomy and fairness : the case of public statements / Chris Willett -- 2. The strategy and the harmonization process within the European legal system : party autonomy and information requirements / Paola Gozzo -- 3. Evolution of party autonomy in a legal system under transformation : recent developments in Poland under special consideration of the Package Travel Directive / Katarzyna Michaowska -- 4. From truth in lending to responsible lending / lain Ramsay -- 5. EC directives for self-employed commercial agents and on time-sharing : apples, oranges and the core of the information overload problem / Bettina Wendlandt -- 6. Information requirements in the E-Commerce Directive and the proposed directive on unfair commercial practices / Annette Nordhausen -- 7. Contractual disclosure and remedies under the Unfair Contract Terms Directive / Edoardo Ferrante -- 8. Information disclosure about the quality of goods : duty or encouragement? / Christian Twigg-Flesner -- 9. Information and product liability : a game of Russian roulette? / Geraint Howells -- 10. Duties to inform versus party autonomy : reversing the paradigm (from free consent to informed consent)? : a comparative account of French and English law / Ruth Sefton-Green -- 11. The information requirements in the principles of European private law 'long-term commercial contracts : commercial agency, distribution, franchise' : a model for a European civil code? / Andre Janssen. |
| Record Nr. | UNINA-9910820728603321 |
| London : , : Routledge, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Das skandinavische Transparenzgebot im europäischen Recht : Herkunft, Entwicklung, Wechselwirkungen und Systematik eines verfahrensrechtlichen Grundsatzes / / Laura Pfirrmann
| Das skandinavische Transparenzgebot im europäischen Recht : Herkunft, Entwicklung, Wechselwirkungen und Systematik eines verfahrensrechtlichen Grundsatzes / / Laura Pfirrmann |
| Autore | Pfirrmann Laura |
| Pubbl/distr/stampa | Baden-Baden, [Germany] : , : Nomos, , 2016 |
| Descrizione fisica | 1 online resource (228 pages) |
| Disciplina | 342.240662 |
| Collana | Schriftenreihe Europäisches Recht, Politik und Wirtschaft |
| Soggetto topico |
Transparency in government - Law and legislation - European Union countries
Transparency in government - Law and legislation - Scandinavia |
| ISBN | 3-8452-4741-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | ger |
| Record Nr. | UNINA-9910150395803321 |
|
Pfirrmann Laura
|
||
| Baden-Baden, [Germany] : , : Nomos, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||