Library Catalogue
Guide EU pharmaceutical regulatory law
Publication details: The Hague Wolter Kluwer 2011Description: 680p xxixSubject(s): DDC classification:- 344.04233 SHO
Contents:
TABLE OF CONTENTS:
About the Editor and Authors;
Foreword;
List of Abbreviations;
Brexit;
CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements;
Sally Shorthose;
CHAPTER 2 Overview of Intellectual Property Rights;
Sally Shorthose & Tasmina Goraya;
CHAPTER 3 Clinical Trials;
Sally Shorthose;
CHAPTER 4 Obtaining a Marketing Authorisation
Sally Shorthose & Sarah Faircliffe;
CHAPTER 5 Conditional Marketing Authorisations;
Sally Shorthose;
CHAPTER 6 Supplementary Protection Certificates;
Tasmina Goraya;
CHAPTER 7 Paediatrics;
Sally Shorthose & Sarah Faircliffe;
CHAPTER 8 Advertising Medicinal Products for Human Use;
Anne-Charlotte Le Bihan, Jean-Baptiste Thiénot, Sally Shorthose, Sarah Faircliffe, Marc Martens, Nicolas Carbonnelle, Ulf Grundmann, Hanneke Later-Nijland, Mauro Turrini, Gabriel Lidman & Raquel Ballesteros;
CHAPTER 9 Pharmacovigilance;
Sally Shorthose
CHAPTER 10 Variations to Marketing Authorisations;
Tasmina Goraya;
CHAPTER 11 Combination Products;
Sarah Faircliffe;
CHAPTER 12 Abridged Procedure;
Hanneke Later-Nijland;
CHAPTER 13 Orphan Drugs;
Sarah Faircliffe;
CHAPTER 14 Biopharmaceuticals;
Marc Martens & Nicolas Carbonnelle;
CHAPTER 15 Homeopathic, Herbal, and Traditional Herbal Medicinal Products;
Hanneke Later-Nijland;
CHAPTER 16 Advanced Therapy Medicinal Products;
Marc Martens & Nicolas Carbonnelle;
CHAPTER 17 Vaccines;
Raquel Ballesteros;
CHAPTER 18 Medical Devices;
Ulf Grundmann, Alexander Csaki, Clarissa Junge-Gierse & David Janiszewski;
CHAPTER 19 Parallel Trade;
Hanneke Later-Nijland;
CHAPTER 20 Competition Law in the Pharmaceutical Sector
José Rivas & Silvia Pronk;
Appendix Guidelines and Publications;
Table of Cases;
Directives;
Other Legislation;
Regulations;
Index.
| Item type | Current library | Shelving location | Call number | Status | Barcode | |
|---|---|---|---|---|---|---|
BOOKs
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NLS | REFERENCE SECTION | 344.04233 SHO (Browse shelf(Opens below)) | Not For Loan | 27808 |
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| 344.041 JOL Routledge handbook of medical law and ethics | 344.041 RAP Medical Liability in Asia and Australia | 344.04194 LOP Regulations regarding living organ donation in Europe : Possibilities of harmonisation | 344.04233 SHO Guide EU pharmaceutical regulatory law | 344.04233 SHO Guide EU pharmaceutical regulatory law | 344.044 GOS Principles of mental health law and policy / | 344.046 ABA Climate change and Indigenous peoples : the search for legal remedies |
TABLE OF CONTENTS:
About the Editor and Authors;
Foreword;
List of Abbreviations;
Brexit;
CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements;
Sally Shorthose;
CHAPTER 2 Overview of Intellectual Property Rights;
Sally Shorthose & Tasmina Goraya;
CHAPTER 3 Clinical Trials;
Sally Shorthose;
CHAPTER 4 Obtaining a Marketing Authorisation
Sally Shorthose & Sarah Faircliffe;
CHAPTER 5 Conditional Marketing Authorisations;
Sally Shorthose;
CHAPTER 6 Supplementary Protection Certificates;
Tasmina Goraya;
CHAPTER 7 Paediatrics;
Sally Shorthose & Sarah Faircliffe;
CHAPTER 8 Advertising Medicinal Products for Human Use;
Anne-Charlotte Le Bihan, Jean-Baptiste Thiénot, Sally Shorthose, Sarah Faircliffe, Marc Martens, Nicolas Carbonnelle, Ulf Grundmann, Hanneke Later-Nijland, Mauro Turrini, Gabriel Lidman & Raquel Ballesteros;
CHAPTER 9 Pharmacovigilance;
Sally Shorthose
CHAPTER 10 Variations to Marketing Authorisations;
Tasmina Goraya;
CHAPTER 11 Combination Products;
Sarah Faircliffe;
CHAPTER 12 Abridged Procedure;
Hanneke Later-Nijland;
CHAPTER 13 Orphan Drugs;
Sarah Faircliffe;
CHAPTER 14 Biopharmaceuticals;
Marc Martens & Nicolas Carbonnelle;
CHAPTER 15 Homeopathic, Herbal, and Traditional Herbal Medicinal Products;
Hanneke Later-Nijland;
CHAPTER 16 Advanced Therapy Medicinal Products;
Marc Martens & Nicolas Carbonnelle;
CHAPTER 17 Vaccines;
Raquel Ballesteros;
CHAPTER 18 Medical Devices;
Ulf Grundmann, Alexander Csaki, Clarissa Junge-Gierse & David Janiszewski;
CHAPTER 19 Parallel Trade;
Hanneke Later-Nijland;
CHAPTER 20 Competition Law in the Pharmaceutical Sector
José Rivas & Silvia Pronk;
Appendix Guidelines and Publications;
Table of Cases;
Directives;
Other Legislation;
Regulations;
Index.