Guide to EU and UK Pharmaceutical Regulatory Law
Samenvatting
Guide to EU and UK Pharmaceutical Regulatory Law, currently in its ninth edition, is a useful book outlining this system with extraordinary clarity and logic. Embracing a Europe-wide perspective on the law governing pharmaceuticals, adept contributors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. 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 that such essential products are not only efficacious but also safe.
Succeeding the brief introductory chapters that provide an overview of the regulatory framework for pharmaceuticals in Europe, a short discussion of how the overarching EU regulatory regime is poised to change in the coming years, and how the exit from the EU by the UK currently affects the regulatory regime, each of the following (twenty-one) incisive chapters examines a particular process or subject.
Among the many topics and issues covered from both an EU and UK perspective – including the all-new chapter on artificial intelligence – 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’;
- homoeopathic, 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.
This unique book will be highly appreciated by pharmaceutical lawyers and regulatory advisers, both in-house and in private practice. It will prove invaluable for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Specificaties
Inhoudsopgave
List of Abbreviations
Preface
CHAPTER 1
Overview of European Pharmaceutical Regulatory Requirements
Sally Shorthose
CHAPTER 2
EU Pharma Package
Sally Shorthose
CHAPTER 3
Brexit
Sally Shorthose
CHAPTER 4
Overview of Intellectual Property Rights
Sally Shorthose, Annika Lückemann, Andrzej Stelmachowski & Sophie Vo
CHAPTER 5
Clinical Trials
Sally Shorthose, Pieter Erasmus, Ana-Maria Barbu-Nyström, Anna Koster & Maud van Haaren
CHAPTER 6
Obtaining a Marketing Authorisation
Sally Shorthose, Sarah Faircliffe & Phillipus Putter
CHAPTER 7
Conditional Marketing Authorisations
Sally Shorthose & Phillipus Putter
CHAPTER 8
Supplementary Protection Certificates
Annika Lückemann, Jan van Dieck, Sophie Vo, Andrzej Stelmachowski & Mark Day
CHAPTER 9
Paediatrics
Sally Shorthose, Sarah Faircliffe & Pieter Erasmus
CHAPTER 10
Advertising Medicinal Products for Human Use
Hester Borgers, Marc Martens, Benedicte Mourisse, Sofia Paksuniemi, Johanna Harelimana, Caroline Arrighi-Savoie, Christian Lindenthal, Annelie Säurig, Denis Halton, Mauro Turrini, Maria Jurek, Andrzej Stelmachowski, Coral Ya´ñez, Alejandra Ine´s Vicario Calleja, Gunnar Hjalt, Ana-Maria Barbu-Nyström & Pieter Erasmus
CHAPTER 11
Pharmacovigilance
Sally Shorthose, Pieter Erasmus, Johanna Harelimana & Nour Saab
CHAPTER 12
Variations to Marketing Authorisations
Caroline Arrighi-Savoie, Johanna Harelimana & Phillipus Putter
CHAPTER 13
Abridged Procedure
Caroline Arrighi-Savoie, Johanna Harelimana & Pieter Erasmus
CHAPTER 14
Orphan Medicinal Products
Sarah Faircliffe & Pieter Erasmus
CHAPTER 15
Biopharmaceuticals
Marc Martens, Benedicte Mourisse & Patrick Brown
CHAPTER 16
Homeopathic, Herbal, and Traditional Herbal Medicinal Products and Cannabis-Based Medicinal Products
Pieter Erasmus, Christian Lindenthal & Annelie Säurig
CHAPTER 17
Advanced Therapy Medicinal Products
Marc Martens, Benedicte Mourisse & Patrick Brown
CHAPTER 18
Vaccines
Sally Shorthose & Phillipus Putter
CHAPTER 19
Medical Devices
Kevin Munungu, Sophie Vo, Maria Jurek, Andrzej Stelmachowski, Kelly Mackey & Maarten Princen
CHAPTER 20
Parallel Trade
Christian Lindenthal, Pieter Erasmus & Annelie Säurig
CHAPTER 21
Competition Law in the Pharmaceutical Sector
Morten Nissen, Peter Willis & Alexander Brøchner
CHAPTER 22
Pandemics and Epidemics
Hester Borgers, Maud van Haaren & Phillipus Putter
CHAPTER 23
Data Protection in the Pharmaceutical Sector
Clara Clark Nevola & Emma Drake
CHAPTER 24
Artificial Intelligence in the Pharmaceutical and Medical Devices Sector
Deirdre Kilroy, Christian Lindenthal, Hester Borgers, Kelly Mackey, Edzard Boonen & Maud van Haaren
Appendix: Guidelines and Publications
Table of Cases
EU Directives
Other Legislation
EU Regulations
Index
Anderen die dit boek kochten, kochten ook
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Tineke Cleiren€ 360,01 -
Bart Krans€ 540,00
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Redactieraad Noordhoff€ 54,50
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Marcel Ruygvoorn€ 50,00
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Karianne Albers€ 66,50
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Joris Fiers€ 68,95
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