Bøker utgitt av Kluwer Law International

In the European Union 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 and 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. 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."

Derived from Kluwer's multi-volume Corporate Acquisitions and Mergers, the largest and most detailed database of M&A know-how available anywhere in the world, this work by a highly experienced partner in the leading international law firm Gorrissen Federspiel provides a concise, practical analysis of current law and practice relating to mergers and acquisitions of public and private companies in Denmark. The book offers a clear explanation of each step in the acquisition process from the perspectives of both the purchaser and the seller. Key areas covered include: structuring the transaction; due diligence; contractual protection; consideration; and the impact of applicable company, competition, tax, intellectual property, environmental and data protection law on the acquisition process. Corporate Acquisitions and Mergers is an invaluable guide for both legal practitioners and business executives seeking a comprehensive yet practical analysis of mergers and acquisitions in Denmark. Equivalent analyses of M&A law and practice in some 50 other jurisdictions, all contributed by leading law firms, are accessible on-line at www.kluwerlawonline.com under Corporate Acquisitions and Mergers.