Navigating European Pharmaceutical Law
Herausgeber: Manley, Maria Isabel; Vickers, Marina
Navigating European Pharmaceutical Law
Herausgeber: Manley, Maria Isabel; Vickers, Marina
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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.
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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.
Produktdetails
- Produktdetails
- Verlag: Oxford University Press, USA
- Seitenzahl: 736
- Erscheinungstermin: 24. November 2015
- Englisch
- Abmessung: 249mm x 165mm x 43mm
- Gewicht: 1379g
- ISBN-13: 9780198717997
- ISBN-10: 0198717997
- Artikelnr.: 47866777
- Verlag: Oxford University Press, USA
- Seitenzahl: 736
- Erscheinungstermin: 24. November 2015
- Englisch
- Abmessung: 249mm x 165mm x 43mm
- Gewicht: 1379g
- ISBN-13: 9780198717997
- ISBN-10: 0198717997
- Artikelnr.: 47866777
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.
* 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
* 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
* 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
* 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