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Contract manufacturing of medicines / by Magdalena Krekora.
2008
F 630 KRE.C
Available at WIPO Library
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Items
Details
Title
Contract manufacturing of medicines / by Magdalena Krekora.
Author
Edition
Third edition.
Description
xiv, 445 pages ; 24 cm.
ISBN
9789041126429
9041126422
9041126422
Alternate Call Number
F 630 KRE.C
Summary
Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of s.
Bibliography, etc. Note
Includes bibliographical references (pages 433-442) and index.
Formatted Contents Note
1. Outsourcing of manufacturing in the pharmaceutical industry; 2. Basic definitions; 3. Manufacturing and importation of medicines - legal aspects; 4. The good manufacturing practice; 5. Contract manufacturing - basic requirements; 6. Regulatory affairs; 7. Quality assurance - basic requirements; 8. The role of the authorized/qualified person; 9. Liability for defective products; 10. Confidentiality; 11. Intellectual property; 12. Deliveries - terms and conditions; 13. Disputes between the parties; 14. Taxes, duties and additional costs; 15. Manufacturing of API; 16. Conclusions.
Series
Kluwer law international.
Published
Alphen aan den Rijn, Netherlands : Kluwer Law International, c2008.
Language
English
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