Ulteriori informazioni
Informationen zum Autor MARIE MANLEY is a Partner at Bristows in London, a law firm specialised in advising technology clients, and head of the Regulatory Department. She advises on IP matters (both contentious and non-contentious), focusing on European and UK regulatory and competition law in the bio-pharma, chemical, cosmetic, medical devices and food sectors; including life cycle management issues, advertising and product liability.MARINA VICKERS is a Senior Associate at Bristows in London, a law firm specialised in advising technology clients. She specialises in EU and UK regulatory law in the biopharma field, both contentious and non-contentious. She has published widely in the field and recently co-authored a chapter on the EU/UK legal framework for an American Bar Association book on Anda litigation strategy. The editors and contributors are delighted to donate all royalties from this edition to the Great Ormond Street Hospital Children's Charity. Klappentext An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance. Zusammenfassung An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance. Inhaltsverzeichnis 1: Introduction 2: Patent Protection for Pharmaceuticals and Biopharmaceutical Products 3: Clinical Trials 4: Procedures for Obtaining a Marketing Authorisation and Legal Bases for Application 5: Pricing, Reimbursement and Health Technology Appraisals 6: Paediatrics 7: Orphan Medicinal Products 8: Biologicals 9: Regulatory Data Protection 10: Supplementary Protection Certificates 11: The Maximisation of IP Regulatory Rights and Lifecycle Management Strategy 12: The interaction between Intellectual Property Law and Competition Law 13: Access to Information 14: Litigating decisions of the regulatory authorities 15: Pharmacovigilance 16: Data Protection 17: The Promotion of Medicinal Products in the EU 18: Borderline Products 19: Product Liability 20: Licensing Consideration 21: Parallel Trade and Stock Management Policies ...
Riassunto
An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance.
