Guide to EU Pharmaceutical Regulatory Law

Edited by Sally Shorthose and contributed to by:
Mary Smillie, Marc Martens, Nicolas Carbonelle, Diane Bandon-Tourret, Ulf Grundmann, Jarste Ackermann, Machteld Hiemstra, Mauro Turrini, Ida Smed Sörensen, Raquel Ballesteros, Morten Nissen, Geoffroy van de Walle de Ghelcke, Melanie Vilarasau, Ina vom Feld, Philipp Neels, Colette Mulder, Victoria Evans, Lorna Brazell and Machteld Hiemstra.

The next edition of Kluwer Law International’s Guide to EU Pharmaceutical Regulatory Law is a unique reference.  It is written by and for lawyers, both in-house and in private practice, who find themselves having to advise a client or clients on this ever-changing area of law, perhaps on the steps needed to bring a product to market including any supplementary obligations (such as the need to conduct a clinical trial of the product for paediatric use), or perhaps when advising on clinical trial agreements, what "normal" rights and obligations of parties should be included in the agreement.
We hope the book will also be of interest and assistance to regulatory advisers. Each chapter presents a particular process or subject from a Europe-wide perspective. The chapters take the reader through the life of a medicinal product or medical device, from development to clinical trials to product launch and afterwards, and we provide guidance in matters where regulatory law is used as an instrument of life-cycle management. With the exception of the advertising chapter, this book deals primarily with the European level of legislation. Where there are significant national deviations or differences in interpretation, we have been able to take advantage of the breadth of Bird & Bird experience in a number of major jurisdictions: UK, France, Germany, Spain, Belgium, The Netherlands, Italy and Sweden to create national variations charts that appear at the end of certain chapters. These charts provide information on how the subject matter of the chapter is implemented in those eight major Member States, and they also serve to illustrate how implementation of the EU regulations varies between Member States. We have only included relevant or significant information so the length of these appendices varies, and for some subjects, such as paediatrics, the legislation is so new and pan-European that we decided that no local variation needed to be included.
In addition, at the end of each chapter we have included a list of guidelines/publications which will direct the readers to sources of additional information. European legislation is peppered with acronyms. For help keeping them all straight, we included a list of the most commonly used ones in the pharmaceutical area, in addition to those that appear in each chapter.

See also:
Guide to EU Pharmaceutical Regulatory Law - 1st Edition
Guide to EU Pharmaceutical Regulatory Law - 3rd Edition

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