Bibliothèque CREDIMI
Catégories
Documents disponibles dans cette catégorie (31)
Affiner la recherche Interroger des sources externes
Information privacy law / SOLOVE, J. Daniel
Titre : Information privacy law Type de document : texte imprimé Auteurs : SOLOVE, J. Daniel, Auteur ; SCHWARTZ, Paul M., Auteur Editeur : Wolters Kluwer Année de publication : 2021 ISBN/ISSN/EAN : 978-1-5438-1372-2 Langues : Anglais (eng) Catégories : Droit européen
Propriété industrielleRésumé : Information Privacy Law is the leading textbook on privacy law. It is used in the majority of privacy law courses at U.S. law schools. With about 1300 pages, the book contains excerpts of key cases, statutes, and scholarly articles. Professors Solove and Schwartz provide useful background, insightful commentary, and thought-provoking questions. Information privacy law [texte imprimé] / SOLOVE, J. Daniel, Auteur ; SCHWARTZ, Paul M., Auteur . - Wolters Kluwer, 2021.
ISBN : 978-1-5438-1372-2
Langues : Anglais (eng)
Catégories : Droit européen
Propriété industrielleRésumé : Information Privacy Law is the leading textbook on privacy law. It is used in the majority of privacy law courses at U.S. law schools. With about 1300 pages, the book contains excerpts of key cases, statutes, and scholarly articles. Professors Solove and Schwartz provide useful background, insightful commentary, and thought-provoking questions. Réservation
Réserver ce document
Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité 3077 XX 2021 SOL Livre CREDIMI 301 XX - Informatique, Droit du numérique, droit des données (RGPD…), IA Disponible Guide to EU and UK Pharmaceutical Regulatory Law / SHORTHOSE, Sally
Titre : Guide to EU and UK Pharmaceutical Regulatory Law Type de document : texte imprimé Auteurs : SHORTHOSE, Sally, Auteur Editeur : Wolters Kluwer Année de publication : 2023 Importance : 920 pages ISBN/ISSN/EAN : 978-94-035-3025-3 Langues : Anglais (eng) Catégories : Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain
Droit européenRésumé : Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides up-to-date information on the processes, legislation, cases, and customs that apply to the introduction, marketing, and sale of a medicinal product (or a medical device) in Europe. Competition law has always been crucial to the pharmaceutical sector since the industry is highly competitive and involves many intellectual property rights. In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe.
What’s in this book:
Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe, each of the following twenty-one incisive chapters, examines a particular process or subject from an EU and UK-wide perspective. Among the many topics and issues covered are the following:
clinical trials;
stages and standards for creating a product dossier;
obtaining a marketing authorisation;
how and when an abridged marketing authorisation procedure can be used;
criteria for conditional marketing authorisations;
generic products and ‘essential similarity’;
paediatric use and the requisite additional trials;
orphan medicinal products;
biologicals and ‘biosimilars’;
homeopathic, herbal and similar medicines;
medical devices;
pandemics, epidemics and vaccines;
pharmacovigilance;
parallel trade;
advertising; and
relevant competition law, intellectual property rights and data protection regulation.
In addition, at the end of each chapter, a list of guidelines/publications has been included that will direct the readers to sources of additional information.
How this will help you:
Dealing primarily with the European level of legislation, the book offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations. This distinctive book will be of high relevance to pharmaceutical lawyers and regulatory advisers, both in-house and in private practice.
Preface
CHAPTER 1
Brexit - Sally Shorthose
CHAPTER 2
Overview of European Pharmaceutical Regulatory Requirements - Sally Shorthose
CHAPTER 3
Overview of Intellectual Property Rights - Sally Shorthose, Marta Sznajder & Jonathan Edwards
CHAPTER 4
Clinical Trials - Sally Shorthose, Pieter Erasmus, Hester Borgers, Edzard Boonen & Anna Koster
CHAPTER 5
Obtaining a Marketing Authorisation - Sally Shorthose, Sarah Faircliffe & Phillipus Putter
CHAPTER 6
Conditional Marketing Authorisations - Sally Shorthose & Jonathan Edwards
CHAPTER 7
Supplementary Protection Certificates - Marta Sznajder & Jonathan Edwards
CHAPTER 8
Paediatrics - Sally Shorthose, Sarah Faircliffe & Pieter Erasmus
CHAPTER 9
Advertising Medicinal Products for Human Use - Hester Borgers & Edzard Boonen (main chapter, the Netherlands); Marc Martens & Benedicte Mourisse (Belgium); Alexandre Vuchot, Johanna Harelimana & Nour Saab (France); Christian Lindenthal & Wolfgang Ernst (Germany); Mauro Turrini (Italy); Coral Yáñez & Ana María Sánchez-Valdepeñas López (Spain); Gabriel Lidman & Gunnar Hjalt (Sweden); and Sally Shorthose, Sarah Faircliffe & Pieter Erasmus (United Kingdom)
CHAPTER 10
Pharmacovigilance - Sally Shorthose, Alexandre Vuchot, Pieter Erasmus, Johanna Harelimana & Nour Saab
CHAPTER 11
Variations to Marketing Authorisations - Alexandre Vuchot, Johanna Harelimana, Nour Saab & Phillipus Putter
CHAPTER 12
Combination Products - Sarah Faircliffe
CHAPTER 13
Abridged Procedure - Pieter Erasmus
CHAPTER 14
Orphan Medicinal Products - Sarah Faircliffe & Pieter Erasmus
CHAPTER 15
Biopharmaceuticals - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 16
Homeopathic, Herbal, and Traditional Herbal Medicinal Products and Cannabis-Based Medicinal Products - Pieter Erasmus
CHAPTER 17
Advanced Therapy Medicinal Products - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 18
Vaccines - Marc Martens & Phillipus Putter
CHAPTER 19
Medical Devices - Kevin Munungu & Sophie Vo
CHAPTER 20
Parallel Trade - Christian Lindenthal, Pieter Erasmus & Jonathan Edwards
CHAPTER 21
Competition Law in the Pharmaceutical Sector - Morten Nissen, Peter Willis & Alexander Brøchner
CHAPTER 22
Pandemics and Epidemics - Hester Borgers, Fenna Douwenga, Edzard Boonen & Phillipus Putter
CHAPTER 23
Data Protection in the Pharmaceutical Sector - Clara Clark Nevola & Emma DrakeGuide to EU and UK Pharmaceutical Regulatory Law [texte imprimé] / SHORTHOSE, Sally, Auteur . - Wolters Kluwer, 2023 . - 920 pages.
ISBN : 978-94-035-3025-3
Langues : Anglais (eng)
Catégories : Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain
Droit européenRésumé : Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides up-to-date information on the processes, legislation, cases, and customs that apply to the introduction, marketing, and sale of a medicinal product (or a medical device) in Europe. Competition law has always been crucial to the pharmaceutical sector since the industry is highly competitive and involves many intellectual property rights. In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe.
What’s in this book:
Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe, each of the following twenty-one incisive chapters, examines a particular process or subject from an EU and UK-wide perspective. Among the many topics and issues covered are the following:
clinical trials;
stages and standards for creating a product dossier;
obtaining a marketing authorisation;
how and when an abridged marketing authorisation procedure can be used;
criteria for conditional marketing authorisations;
generic products and ‘essential similarity’;
paediatric use and the requisite additional trials;
orphan medicinal products;
biologicals and ‘biosimilars’;
homeopathic, herbal and similar medicines;
medical devices;
pandemics, epidemics and vaccines;
pharmacovigilance;
parallel trade;
advertising; and
relevant competition law, intellectual property rights and data protection regulation.
In addition, at the end of each chapter, a list of guidelines/publications has been included that will direct the readers to sources of additional information.
How this will help you:
Dealing primarily with the European level of legislation, the book offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations. This distinctive book will be of high relevance to pharmaceutical lawyers and regulatory advisers, both in-house and in private practice.
Preface
CHAPTER 1
Brexit - Sally Shorthose
CHAPTER 2
Overview of European Pharmaceutical Regulatory Requirements - Sally Shorthose
CHAPTER 3
Overview of Intellectual Property Rights - Sally Shorthose, Marta Sznajder & Jonathan Edwards
CHAPTER 4
Clinical Trials - Sally Shorthose, Pieter Erasmus, Hester Borgers, Edzard Boonen & Anna Koster
CHAPTER 5
Obtaining a Marketing Authorisation - Sally Shorthose, Sarah Faircliffe & Phillipus Putter
CHAPTER 6
Conditional Marketing Authorisations - Sally Shorthose & Jonathan Edwards
CHAPTER 7
Supplementary Protection Certificates - Marta Sznajder & Jonathan Edwards
CHAPTER 8
Paediatrics - Sally Shorthose, Sarah Faircliffe & Pieter Erasmus
CHAPTER 9
Advertising Medicinal Products for Human Use - Hester Borgers & Edzard Boonen (main chapter, the Netherlands); Marc Martens & Benedicte Mourisse (Belgium); Alexandre Vuchot, Johanna Harelimana & Nour Saab (France); Christian Lindenthal & Wolfgang Ernst (Germany); Mauro Turrini (Italy); Coral Yáñez & Ana María Sánchez-Valdepeñas López (Spain); Gabriel Lidman & Gunnar Hjalt (Sweden); and Sally Shorthose, Sarah Faircliffe & Pieter Erasmus (United Kingdom)
CHAPTER 10
Pharmacovigilance - Sally Shorthose, Alexandre Vuchot, Pieter Erasmus, Johanna Harelimana & Nour Saab
CHAPTER 11
Variations to Marketing Authorisations - Alexandre Vuchot, Johanna Harelimana, Nour Saab & Phillipus Putter
CHAPTER 12
Combination Products - Sarah Faircliffe
CHAPTER 13
Abridged Procedure - Pieter Erasmus
CHAPTER 14
Orphan Medicinal Products - Sarah Faircliffe & Pieter Erasmus
CHAPTER 15
Biopharmaceuticals - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 16
Homeopathic, Herbal, and Traditional Herbal Medicinal Products and Cannabis-Based Medicinal Products - Pieter Erasmus
CHAPTER 17
Advanced Therapy Medicinal Products - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 18
Vaccines - Marc Martens & Phillipus Putter
CHAPTER 19
Medical Devices - Kevin Munungu & Sophie Vo
CHAPTER 20
Parallel Trade - Christian Lindenthal, Pieter Erasmus & Jonathan Edwards
CHAPTER 21
Competition Law in the Pharmaceutical Sector - Morten Nissen, Peter Willis & Alexander Brøchner
CHAPTER 22
Pandemics and Epidemics - Hester Borgers, Fenna Douwenga, Edzard Boonen & Phillipus Putter
CHAPTER 23
Data Protection in the Pharmaceutical Sector - Clara Clark Nevola & Emma DrakeRéservation
Réserver ce document
Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité 3083 XXV 2023 SHO Livre CREDIMI 301 Section à déterminer Disponible Les accords de libre-échange de l'Union européenne / Alan HERVÉ
Titre : Les accords de libre-échange de l'Union européenne : Modèle de régulation du commerce international Par Alan Hervé Type de document : texte imprimé Auteurs : Alan HERVÉ, Auteur Editeur : Bruylant Année de publication : 2023 Format : Broché ISBN/ISSN/EAN : 978-2-8027-7276-7 Langues : Français (fre) Catégories : Droit du commerce, droit du commerce international
Droit économique, droit du marché
Droit européenMots-clés : libre-échange accords Union Européenne échanges commerciaux commerce international Résumé : Des accords de libre-échange qui permettent à l'UE de réguler la mondialisation et sécuriser les échanges commerciaux.
Par-delà sa dimension technique et pratique, cet ouvrage permet en définitive de mieux comprendre la façon dont l'Union européenne tente, avec ces accords, de réguler la mondialisation et de sécuriser ses échanges commerciaux.
Les accords de libre-échange de l'Union européenne : Modèle de régulation du commerce international Par Alan Hervé [texte imprimé] / Alan HERVÉ, Auteur . - Bruylant, 2023 . - ; Broché.
ISBN : 978-2-8027-7276-7
Langues : Français (fre)
Catégories : Droit du commerce, droit du commerce international
Droit économique, droit du marché
Droit européenMots-clés : libre-échange accords Union Européenne échanges commerciaux commerce international Résumé : Des accords de libre-échange qui permettent à l'UE de réguler la mondialisation et sécuriser les échanges commerciaux.
Par-delà sa dimension technique et pratique, cet ouvrage permet en définitive de mieux comprendre la façon dont l'Union européenne tente, avec ces accords, de réguler la mondialisation et de sécuriser ses échanges commerciaux.
Réservation
Réserver ce document
Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité 3041 VI 2023 HER Livre CREDIMI 301 VI - Droit international économique (mondialisation, OMC, pays émergents Disponible Boundaries of european private international law / Jean-Sylvestre BERGÉ
Titre : Boundaries of european private international law Titre original : Les frontières du droit international privé européen, Las fronteras del derecho internacional privado europeo Type de document : texte imprimé Auteurs : Jean-Sylvestre BERGÉ , Auteur ; Stéphanie FRANCQ, Auteur ; Miguel GARDEÑES SANTIAGO , Auteur Editeur : Bruylant Année de publication : 2015 Importance : 720 pages Format : Broché ISBN/ISSN/EAN : 978-2-8027-4697-3 Langues : Français (fre) Anglais (eng) Espagnol (spa) Catégories : Droit économique, droit du marché
Droit européen
Droit international PrivéMots-clés : mediation agreement compétence judiciaire reconnaissance des décisions obligations contractuelles Bruxelles II bis lis pendens Bruxelles I bis clauses d'articulation neutrality conflit de lois Index. décimale : 340.9 : Droit international privé (conflits de droit, conflits de lois, ensemble des règles régissant le choix ...) Résumé : European private international law is by now based mainly on a large body of uniform rules such as the Regulations Rome I, Rome II, Brussels I, Brussels I bis. This significant legislative output, however, does not take place in a vacuum. Rules of private international law have been earlier (and still are) adopted at national, international and even European level in scattered regulations and directives. The recent plethora of private international law rules gives rise to issues of delineation and calls for some sort of ordering as gaps, overlaps and contradictions become flagrant. At the same time, the resulting interactions can offer new insight, ideas and even opportunities at a more theoretical level.
This book gathers a collection of essays resulting out of a series of international seminars held in Lyon, Barcelona and Louvain-la-Neuve. During those seminars, young researchers selected in an open call for papers had the opportunity to discuss their views among themselves as well as with various specialists of the field, such as more senior academics, EU civil servants, national experts and representatives of other international organisations. The book offers the fresh views of those who will in the future shape the dialectic between the various sources of private international law and attempts to launch a discussion on the “living together” of legal sources.
Two ranges of topics are addressed in the book:
- firstly, the relationship between EU private international law and national law (substantial and procedural) and/or international law (international instruments of private international law or of uniform substantive law); and
- secondly, the relationship between EU private international law and other aspects of EU law (internal market rules of primary law, harmonisation through secondary law and other pieces of legislation enacted in the realm of the area of freedom, security and justice).
Note de contenu : Droit international privé (droit européen) : Actes de congrès
Droit international et droit interne : Pays de l'Union européenne : Actes de congrès
Publ. dans le cadre du programme européen de recherche "Jean Monnet Lifelong learning-projet", supervisé par le Centre de recherche sur le droit international privé et le Réseau universitaire européen Droit et espace de liberté sécurité et justice. Issu de deux colloques tenus respectivement à Barcelone les 27 et 28 mars 2014 et à Louvain-la-Neuve, les 5 et 6 juin 2014.
Résumés en anglais, espagnol et français.
Diffusé en France.
Mention parallèle de titre ou de responsabilité : Les frontières du droit international privé européen.
Mention parallèle de titre ou de responsabilité : Las fronteras del derecho internacional privado europeoBoundaries of european private international law = Les frontières du droit international privé européen, Las fronteras del derecho internacional privado europeo [texte imprimé] / Jean-Sylvestre BERGÉ , Auteur ; Stéphanie FRANCQ, Auteur ; Miguel GARDEÑES SANTIAGO , Auteur . - Bruylant, 2015 . - 720 pages ; Broché.
ISBN : 978-2-8027-4697-3
Langues : Français (fre) Anglais (eng) Espagnol (spa)
Catégories : Droit économique, droit du marché
Droit européen
Droit international PrivéMots-clés : mediation agreement compétence judiciaire reconnaissance des décisions obligations contractuelles Bruxelles II bis lis pendens Bruxelles I bis clauses d'articulation neutrality conflit de lois Index. décimale : 340.9 : Droit international privé (conflits de droit, conflits de lois, ensemble des règles régissant le choix ...) Résumé : European private international law is by now based mainly on a large body of uniform rules such as the Regulations Rome I, Rome II, Brussels I, Brussels I bis. This significant legislative output, however, does not take place in a vacuum. Rules of private international law have been earlier (and still are) adopted at national, international and even European level in scattered regulations and directives. The recent plethora of private international law rules gives rise to issues of delineation and calls for some sort of ordering as gaps, overlaps and contradictions become flagrant. At the same time, the resulting interactions can offer new insight, ideas and even opportunities at a more theoretical level.
This book gathers a collection of essays resulting out of a series of international seminars held in Lyon, Barcelona and Louvain-la-Neuve. During those seminars, young researchers selected in an open call for papers had the opportunity to discuss their views among themselves as well as with various specialists of the field, such as more senior academics, EU civil servants, national experts and representatives of other international organisations. The book offers the fresh views of those who will in the future shape the dialectic between the various sources of private international law and attempts to launch a discussion on the “living together” of legal sources.
Two ranges of topics are addressed in the book:
- firstly, the relationship between EU private international law and national law (substantial and procedural) and/or international law (international instruments of private international law or of uniform substantive law); and
- secondly, the relationship between EU private international law and other aspects of EU law (internal market rules of primary law, harmonisation through secondary law and other pieces of legislation enacted in the realm of the area of freedom, security and justice).
Note de contenu : Droit international privé (droit européen) : Actes de congrès
Droit international et droit interne : Pays de l'Union européenne : Actes de congrès
Publ. dans le cadre du programme européen de recherche "Jean Monnet Lifelong learning-projet", supervisé par le Centre de recherche sur le droit international privé et le Réseau universitaire européen Droit et espace de liberté sécurité et justice. Issu de deux colloques tenus respectivement à Barcelone les 27 et 28 mars 2014 et à Louvain-la-Neuve, les 5 et 6 juin 2014.
Résumés en anglais, espagnol et français.
Diffusé en France.
Mention parallèle de titre ou de responsabilité : Les frontières du droit international privé européen.
Mention parallèle de titre ou de responsabilité : Las fronteras del derecho internacional privado europeoRéservation
Réserver ce document
Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité 0029 III 2015 BER Livre CREDIMI 301 III - Droit international privé (national, européen et comparé) Disponible Brussels II bis regulation / Ulrich MAGNUS
Titre : Brussels II bis regulation Type de document : texte imprimé Auteurs : Ulrich MAGNUS, Auteur ; Peter MANKOWSKI, Auteur Année de publication : 2012 Importance : 506 pages ISBN/ISSN/EAN : 978-3-935808-33-0 Langues : Anglais (eng) Catégories : Droit européen
Droit international Privé
Sources du droit et ouvrages généraux en droitMots-clés : Bruxelles II BIS commentaire droit privé divorce responsabilité parentale Résumé : This new series will comment on the Brussels I Regulation and the Brussels IIbis Regulation and as soon as they are enacted on the Rome I and the Rome II Regulation. For the first time this will be done by a team of leading experts from almost all EU member states. The close cooperation among them will initiate a new specific European style of commenting on European enactments merging the various and thus far nationwide differing methods of Interpretation of legislative acts. It goes without saying that the new commentaries will pay particular tribute to the practice of the European Court of Justice but to relevant judgments of national courts as well. Moreover, the needs of practitioners and the requirements of the practice will receive particular attention. The series is intended to be continued by further volumes on existing and future European enactments in the field of private and procedural law. Note de contenu : Procédure (droit européen)
Juridiction : Pays de l'Union européenne
Jugements étrangers (droit européen)
Civil procedure : European Union countriesBrussels II bis regulation [texte imprimé] / Ulrich MAGNUS, Auteur ; Peter MANKOWSKI, Auteur . - 2012 . - 506 pages.
ISBN : 978-3-935808-33-0
Langues : Anglais (eng)
Catégories : Droit européen
Droit international Privé
Sources du droit et ouvrages généraux en droitMots-clés : Bruxelles II BIS commentaire droit privé divorce responsabilité parentale Résumé : This new series will comment on the Brussels I Regulation and the Brussels IIbis Regulation and as soon as they are enacted on the Rome I and the Rome II Regulation. For the first time this will be done by a team of leading experts from almost all EU member states. The close cooperation among them will initiate a new specific European style of commenting on European enactments merging the various and thus far nationwide differing methods of Interpretation of legislative acts. It goes without saying that the new commentaries will pay particular tribute to the practice of the European Court of Justice but to relevant judgments of national courts as well. Moreover, the needs of practitioners and the requirements of the practice will receive particular attention. The series is intended to be continued by further volumes on existing and future European enactments in the field of private and procedural law. Note de contenu : Procédure (droit européen)
Juridiction : Pays de l'Union européenne
Jugements étrangers (droit européen)
Civil procedure : European Union countriesRéservation
Réserver ce document
Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité 0028 III 2012 MAG Livre CREDIMI 301 III - Droit international privé (national, européen et comparé) Disponible Commentaries on European contract laws / Reinhard ZIMMERMANN
PermalinkLa concurrence réglementaire, sociale et fiscale dans l'Union européenne / Éric CARPANO
PermalinkDimensions of Evidence in European Civil Procedure
PermalinkPermalinkDroit européen comparé des contrats / Rémy CABRILLAC
PermalinkDroit européen des contrats / Hein KÖTZ
PermalinkLe droit européen et l'investissement / Catherine KESSEDJIAN
PermalinkDroit de l'Union européenne et lois de police / Elena-Alina OPREA
PermalinkEU Investment Protection Law / Moritz KELLER
PermalinkEU Law and International Arbitration / Konstanze VON PAPP
Permalink