Guide to EU Pharmaceutical Regulatory Law - Softcover

Shorthose, Sally

Softcover

ISBN 10: 9041169520 ISBN 13: 9789041169525

Publisher: Kluwer Law International, 2017

Synopsis

In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors 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. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe from its underlying rationales to the relevant committees and agencies each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and essential similarity; - paediatric use and the requisite additional trials; - biologicals and biosimilars; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It 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.

About this title

About the Author

Sally joined Bird & Bird in September 2006 as a Partner in the Intellectual Property Group, based in London. After studying law at Manchester University and then the College of Law, she completed her training at Herbert Smith and qualified in 1988. After a period as a solicitor at Herbert Smith, Sally spent eleven years working in-house firstly as senior legal advisor at ICI/Zeneca and latterly as Legal Director of Novartis UK, where she was responsible for all legal matters for the Novartis Group within the UK with particular responsibility for intellectual property protection, regulatory compliance and competition law compliance. She was Head of IP and Life Sciences at another international firm before joining Bird & Bird. As a transactional IP lawyer, Sally has been involved in providing advice in relation to the protection and exploitation of a full range of intellectual property rights, from design rights to patents, trade marks, copyright and confidentiality across a range of jurisdictions, both in stand alone transactions and in conjunction with her corporate colleagues as part of an acquisition, divestment or investment activity. Sally provides a full range of IP commercial advice and support to her clients, including licensing, partnering joint ventures and exploitation agreements, research, development and marketing collaborations. She also frequently advises clients on regulatory and freedom to operate matters, and manages significant due diligence matters. Sally is a regular speaker at conferences and seminars on a range of IP related subjects, particularly in relation to regulatory, licensing and exploitation matters.

About this edition

• Publisher: Kluwer Law International
• Publication date: 2017
• ISBN 10: 9041169520
• ISBN 13: 9789041169525
• Binding: Paperback
• Number of pages: 832
• Editor: Shorthose Sally