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 information as a human right [[electronic resource] /] / Cheryl Ann Bishop
| Access to information as a human right [[electronic resource] /] / Cheryl Ann Bishop |
| Autore | Bishop Cheryl Ann <1964-> |
| Pubbl/distr/stampa | El Paso, : LFB Scholarly Pub., 2012 |
| Descrizione fisica | 1 online resource (241 p.) |
| Disciplina | 342.08/53 |
| Collana | Law and society |
| Soggetto topico | Freedom of information |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-59332-505-3 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Freedom-of-expression conceptualization -- Information-privacy conceptualization -- Right-to-a-healthy-environment conceptualization -- Right-to-truth conceptualization -- Conclusions. |
| Record Nr. | UNINA-9910462419603321 |
Bishop Cheryl Ann <1964->
|
||
| El Paso, : LFB Scholarly Pub., 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Access to information as a human right [[electronic resource] /] / Cheryl Ann Bishop
| Access to information as a human right [[electronic resource] /] / Cheryl Ann Bishop |
| Autore | Bishop Cheryl Ann <1964-> |
| Pubbl/distr/stampa | El Paso, : LFB Scholarly Pub., 2012 |
| Descrizione fisica | 1 online resource (241 p.) |
| Disciplina | 342.08/53 |
| Collana | Law and society |
| Soggetto topico | Freedom of information |
| ISBN | 1-59332-505-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Freedom-of-expression conceptualization -- Information-privacy conceptualization -- Right-to-a-healthy-environment conceptualization -- Right-to-truth conceptualization -- Conclusions. |
| Record Nr. | UNINA-9910790263903321 |
|
Bishop Cheryl Ann <1964->
|
||
| El Paso, : LFB Scholarly Pub., 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Access to information as a human right [[electronic resource] /] / Cheryl Ann Bishop
| Access to information as a human right [[electronic resource] /] / Cheryl Ann Bishop |
| Autore | Bishop Cheryl Ann <1964-> |
| Pubbl/distr/stampa | El Paso, : LFB Scholarly Pub., 2012 |
| Descrizione fisica | 1 online resource (241 p.) |
| Disciplina | 342.08/53 |
| Collana | Law and society |
| Soggetto topico | Freedom of information |
| ISBN | 1-59332-505-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Freedom-of-expression conceptualization -- Information-privacy conceptualization -- Right-to-a-healthy-environment conceptualization -- Right-to-truth conceptualization -- Conclusions. |
| Record Nr. | UNINA-9910812754503321 |
|
Bishop Cheryl Ann <1964->
|
||
| El Paso, : LFB Scholarly Pub., 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 | ||
| ||
Annual FOIA report
| Annual FOIA report |
| Pubbl/distr/stampa | Washington, D.C., : National Indian Gaming Commission |
| Descrizione fisica | volumes : digital, PDF file |
| Disciplina | 795 |
| Soggetto topico |
Freedom of information - United States
Government information - United States Freedom of information Government information |
| Soggetto genere / forma |
Periodicals.
Statistics. |
| ISSN | 2151-9021 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Annual Freedom of Information Act report
FOIA annual reports |
| Record Nr. | UNINA-9910702841503321 |
| Washington, D.C., : National Indian Gaming Commission | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Annual freedom of information act (FOIA) report
| Annual freedom of information act (FOIA) report |
| Pubbl/distr/stampa | Washington, DC, : NASA Headquarters |
| Descrizione fisica | 1 online resource (volumes) |
| Disciplina | 354 |
| Soggetto topico |
Freedom of information - United States
Government information - United States Freedom of information Government information |
| Soggetto genere / forma | Periodicals. |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Annual freedom of information act report
Current FOIA report FOIA report |
| Record Nr. | UNINA-9910693444703321 |
| Washington, DC, : NASA Headquarters | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Article 17 [[electronic resource] ] : access to a diversity of mass media sources / / by Sherry Wheatley Sacino
| Article 17 [[electronic resource] ] : access to a diversity of mass media sources / / by Sherry Wheatley Sacino |
| Autore | Sacino Sherry Wheatley |
| Pubbl/distr/stampa | Leiden, : Martinus Nijhoff Publishers, 2012 |
| Descrizione fisica | 1 online resource (112 p.) |
| Disciplina | 341.4/8572 |
| Collana | Commentary on the United Nations Convention on the Rights of the Child |
| Soggetto topico |
Freedom of information
Mass media - Law and legislation Children (International law) Children's rights |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-283-39585-1
9786613395856 90-04-21692-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Comparison with related human rights provisions -- Scope of Article 17 -- The second sentence of Article 17 -- Implementation of Article 17 as seen through the perspectives of the Committee -- Challenges. |
| Altri titoli varianti | Article seventeen |
| Record Nr. | UNINA-9910461568303321 |
|
Sacino Sherry Wheatley
|
||
| Leiden, : Martinus Nijhoff Publishers, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Article 17 [[electronic resource] ] : access to a diversity of mass media sources / / by Sherry Wheatley Sacino
| Article 17 [[electronic resource] ] : access to a diversity of mass media sources / / by Sherry Wheatley Sacino |
| Autore | Sacino Sherry Wheatley |
| Pubbl/distr/stampa | Leiden, : Martinus Nijhoff Publishers, 2012 |
| Descrizione fisica | 1 online resource (112 p.) |
| Disciplina | 341.4/8572 |
| Collana | Commentary on the United Nations Convention on the Rights of the Child |
| Soggetto topico |
Freedom of information
Mass media - Law and legislation Children (International law) Children's rights |
| ISBN |
1-283-39585-1
9786613395856 90-04-21692-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Comparison with related human rights provisions -- Scope of Article 17 -- The second sentence of Article 17 -- Implementation of Article 17 as seen through the perspectives of the Committee -- Challenges. |
| Altri titoli varianti | Article seventeen |
| Record Nr. | UNINA-9910789875103321 |
|
Sacino Sherry Wheatley
|
||
| Leiden, : Martinus Nijhoff Publishers, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Article 17 [[electronic resource] ] : access to a diversity of mass media sources / / by Sherry Wheatley Sacino
| Article 17 [[electronic resource] ] : access to a diversity of mass media sources / / by Sherry Wheatley Sacino |
| Autore | Sacino Sherry Wheatley |
| Pubbl/distr/stampa | Leiden, : Martinus Nijhoff Publishers, 2012 |
| Descrizione fisica | 1 online resource (112 p.) |
| Disciplina | 341.4/8572 |
| Collana | Commentary on the United Nations Convention on the Rights of the Child |
| Soggetto topico |
Freedom of information
Mass media - Law and legislation Children (International law) Children's rights |
| ISBN |
1-283-39585-1
9786613395856 90-04-21692-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Comparison with related human rights provisions -- Scope of Article 17 -- The second sentence of Article 17 -- Implementation of Article 17 as seen through the perspectives of the Committee -- Challenges. |
| Altri titoli varianti | Article seventeen |
| Record Nr. | UNINA-9910823945603321 |
|
Sacino Sherry Wheatley
|
||
| Leiden, : Martinus Nijhoff Publishers, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Calidad informativa en la era de la digitalización : fundamentos profesionales vs. infopolución / / editora, Carmen Marta, Lazo
| Calidad informativa en la era de la digitalización : fundamentos profesionales vs. infopolución / / editora, Carmen Marta, Lazo |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Madrid : , : Dykinson, , 2018 |
| Descrizione fisica | 1 online resource (208 páginas) : ilustraciones |
| Disciplina | 070.4 |
| Soggetto topico |
Online journalism
Mass media - Social aspects Freedom of information Periodismo Internet Medios de comunicación de masas Libertad de información |
| Soggetto genere / forma | Libros electronicos. |
| ISBN | 84-9148-947-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910793227403321 |
| Madrid : , : Dykinson, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
