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Titre : Les Grands Arrêts de droit vitivinicole Type de document : texte imprimé Auteurs : Théodore GEORGOPOULOS, Auteur Editeur : Mare & Martin Année de publication : 2022 Collection : Vin & droit Importance : 630 pages Format : Broché ISBN/ISSN/EAN : 978-2-84934-687-7 Langues : Français (fre) Catégories : Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain
Droit économique, droit du marché
Droit européen
Sources du droit et ouvrages généraux en droitMots-clés : vin vins biologiques droit vitivinicole arrêts jurisprudence politique agricole commune droit du vin Cour de justice de l'Union européen CJUE Résumé : Le présent ouvrage propose une appréhension du droit de la vigne et du vin à contre-courant. Traditionnellement considéré comme un faisceau de règles techniques, issues du code rural et du code la consommation ainsi que de règlements de la Politique Agricole commune, le droit de la vigne et du vin n’est que rarement approfondi à partir de la jurisprudence, aussi bien nationale et européenne. Or, il s’avère que les tribunaux ne se contentent pas de « dire la loi » du vin ; ils contribuent aussi à son approfondissement et à la perfection d’un véritable système juridique avec sa cohérence et ses spécificités.
Les 35 commentaires, rédigés par 27 spécialistes de la discipline, articulés à partir des grandes thématiques du droit vitivinicole, et complétés par des mots-clés et une bibliographie sélective pour aller plus loin, permettent d’esquisser les contours de ce système et même de laisser entrevoir l’existence d’une « école » française en la matière.Les Grands Arrêts de droit vitivinicole [texte imprimé] / Théodore GEORGOPOULOS, Auteur . - Mare & Martin, 2022 . - 630 pages ; Broché. - (Vin & droit) .
ISBN : 978-2-84934-687-7
Langues : Français (fre)
Catégories : Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain
Droit économique, droit du marché
Droit européen
Sources du droit et ouvrages généraux en droitMots-clés : vin vins biologiques droit vitivinicole arrêts jurisprudence politique agricole commune droit du vin Cour de justice de l'Union européen CJUE Résumé : Le présent ouvrage propose une appréhension du droit de la vigne et du vin à contre-courant. Traditionnellement considéré comme un faisceau de règles techniques, issues du code rural et du code la consommation ainsi que de règlements de la Politique Agricole commune, le droit de la vigne et du vin n’est que rarement approfondi à partir de la jurisprudence, aussi bien nationale et européenne. Or, il s’avère que les tribunaux ne se contentent pas de « dire la loi » du vin ; ils contribuent aussi à son approfondissement et à la perfection d’un véritable système juridique avec sa cohérence et ses spécificités.
Les 35 commentaires, rédigés par 27 spécialistes de la discipline, articulés à partir des grandes thématiques du droit vitivinicole, et complétés par des mots-clés et une bibliographie sélective pour aller plus loin, permettent d’esquisser les contours de ce système et même de laisser entrevoir l’existence d’une « école » française en la matière.Réservation
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Code-barres Cote Support Localisation Section Disponibilité 3020 II 2022 GEO Livre CREDIMI 301 II - Sources du droit et ouvrages généraux en droit (ex. : pluralisme…) Disponible
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 MarÃa 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 MarÃa 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
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Code-barres Cote Support Localisation Section Disponibilité 3083 XXV 2023 SHO Livre CREDIMI 301 Section à déterminer Disponible
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
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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
Titre : International Commercial Litigation : Text, cases and materials on private international law Type de document : texte imprimé Auteurs : Trevor Clayton HARTLEY, Auteur Editeur : Cambridge University Press Année de publication : 2020 Importance : 1022 pages Format : Broché ISBN/ISSN/EAN : 978-1-108-72113-4 Langues : Anglais (eng) Catégories : Droit comparé et droits étrangers
Droit européen
Droit international PrivéMots-clés : jurisdiction domicile contracts harmful event financial loss minimum contacts doctrine choice-of-court agreements jurisdictional conflicts foreign judgments choice of law Résumé : Taking a fresh and modern approach to the subject, this fully revised and restructured textbook provides everything necessary to gain a good understanding of international commercial litigation. Adopting a comparative stance, it provides extensive coverage of US and Commonwealth law, in addition to the core areas of English and EU law. Extracts from key cases and legislative acts are designed to meet the practical requirements of litigators as well as explaining the ideas behind legal provisions. Significant updates include coverage of new case-law from the Court of Justice of the European Union. Of particular importance has been a set of judgments on jurisdiction in tort for pure financial loss, many of which have involved investment loss. New case law from the English courts, including the Supreme Court, and from the Supreme Court of the United States, is also covered. Note de contenu : Droit commercial (droit international)
Droit commercial (droit européen)
Arbitrage commercial international
Commercial law
Conflict of laws : Commercial lawInternational Commercial Litigation : Text, cases and materials on private international law [texte imprimé] / Trevor Clayton HARTLEY, Auteur . - Cambridge University Press, 2020 . - 1022 pages ; Broché.
ISBN : 978-1-108-72113-4
Langues : Anglais (eng)
Catégories : Droit comparé et droits étrangers
Droit européen
Droit international PrivéMots-clés : jurisdiction domicile contracts harmful event financial loss minimum contacts doctrine choice-of-court agreements jurisdictional conflicts foreign judgments choice of law Résumé : Taking a fresh and modern approach to the subject, this fully revised and restructured textbook provides everything necessary to gain a good understanding of international commercial litigation. Adopting a comparative stance, it provides extensive coverage of US and Commonwealth law, in addition to the core areas of English and EU law. Extracts from key cases and legislative acts are designed to meet the practical requirements of litigators as well as explaining the ideas behind legal provisions. Significant updates include coverage of new case-law from the Court of Justice of the European Union. Of particular importance has been a set of judgments on jurisdiction in tort for pure financial loss, many of which have involved investment loss. New case law from the English courts, including the Supreme Court, and from the Supreme Court of the United States, is also covered. Note de contenu : Droit commercial (droit international)
Droit commercial (droit européen)
Arbitrage commercial international
Commercial law
Conflict of laws : Commercial lawRéservation
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Code-barres Cote Support Localisation Section Disponibilité 0038 III 2020 HAR Livre CREDIMI 301 III - Droit international privé (national, européen et comparé) Disponible
Titre : International Contracting : Law and Practice Type de document : texte imprimé Auteurs : Larry DI MATTEO, Auteur Mention d'édition : 3ème édition Editeur : KLUWER LAW INTERNATIONAL Année de publication : 2013 Importance : 679 pages Format : Relié ISBN/ISSN/EAN : 978-90-411-3530-8 Langues : Anglais (eng) Catégories : Droit du commerce, droit du commerce international
Droit européenMots-clés : contrats internationaux usages du commerce international contrats d'export droit européen principes contractuels vente Index. décimale : 000 - pas d'indexation décimale connue Résumé : For more than a decade this prized guide has served practitioners handling the legal ramifications of international contracting projects. The Third Edition thoroughly describes the new and ever-changing concepts and procedures that continue to redefine the searching, drafting, and execution of international contracts. More profoundly, it takes fully into account the impact of the financial crisis of 2008 on the legal profession, the regulatory system, and how we view certain types of contractual instruments. All the invaluable features of earlier editions are of course still here, including analysis of key contract issues unique to various types of contracting, common contract clauses (such as choice of law and dispute resolution clauses), contract checklists, insights gleaned from actual cases and arbitral proceedings, and clear explanation of the principles of good contract drafting. The major relevant international conventions, model laws, pertinent national laws, legal guides, and other documents and instruments are all covered, with primary texts provided in appendices. The bibliography (including online sources) is once more greatly expanded and enhanced. The Third Edition introduces the idea of proactive or strategic contracting, and adds a new chapter on confidentiality, nondisclosure agreements, and covenants not to compete. Other new and updated material examines such issues and topics as the following: anti-bribery clauses; garden leave clauses; strategic posturing; countertrade; guarantees of performance; mediation rules; performance bonds; and contract interpretation. Updates on relevant developments worldwide include new material on China, the European Union (including the important Common European Sales Law), Germany, Scandinavia, Russia, and Australia. The important new United Nations Convention on the Use of Electronic Communications in International Contracts is also covered. Given the legal liability that can result from the failure to take private international law developments into account, this book is not only valuable but necessary. International Contracting : Law and Practice [texte imprimé] / Larry DI MATTEO, Auteur . - 3ème édition . - KLUWER LAW INTERNATIONAL, 2013 . - 679 pages ; Relié.
ISBN : 978-90-411-3530-8
Langues : Anglais (eng)
Catégories : Droit du commerce, droit du commerce international
Droit européenMots-clés : contrats internationaux usages du commerce international contrats d'export droit européen principes contractuels vente Index. décimale : 000 - pas d'indexation décimale connue Résumé : For more than a decade this prized guide has served practitioners handling the legal ramifications of international contracting projects. The Third Edition thoroughly describes the new and ever-changing concepts and procedures that continue to redefine the searching, drafting, and execution of international contracts. More profoundly, it takes fully into account the impact of the financial crisis of 2008 on the legal profession, the regulatory system, and how we view certain types of contractual instruments. All the invaluable features of earlier editions are of course still here, including analysis of key contract issues unique to various types of contracting, common contract clauses (such as choice of law and dispute resolution clauses), contract checklists, insights gleaned from actual cases and arbitral proceedings, and clear explanation of the principles of good contract drafting. The major relevant international conventions, model laws, pertinent national laws, legal guides, and other documents and instruments are all covered, with primary texts provided in appendices. The bibliography (including online sources) is once more greatly expanded and enhanced. The Third Edition introduces the idea of proactive or strategic contracting, and adds a new chapter on confidentiality, nondisclosure agreements, and covenants not to compete. Other new and updated material examines such issues and topics as the following: anti-bribery clauses; garden leave clauses; strategic posturing; countertrade; guarantees of performance; mediation rules; performance bonds; and contract interpretation. Updates on relevant developments worldwide include new material on China, the European Union (including the important Common European Sales Law), Germany, Scandinavia, Russia, and Australia. The important new United Nations Convention on the Use of Electronic Communications in International Contracts is also covered. Given the legal liability that can result from the failure to take private international law developments into account, this book is not only valuable but necessary. Réservation
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Code-barres Cote Support Localisation Section Disponibilité 0799 V 2013 DIM Livre CREDIMI 301 V - Droit du commerce (interne et étranger), droit du commerce international Disponible La matière civile et commerciale, socle d'un code européen de droit international privé ? / Marc FALLON
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