- Format
- Inbunden (Hardback)
- Språk
- Engelska
- Antal sidor
- 736
- Utgivningsdatum
- 2015-09-24
- Förlag
- OUP Oxford
- Medarbetare
- Vickers, Marina
- Dimensioner
- 249 x 165 x 43 mm
- Vikt
- Antal komponenter
- 1
- ISBN
- 9780198717997
- 1380 g
Navigating European Pharmaceutical Law
An Expert's Guide
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Övrig information
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.
Innehållsförteckning
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
