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Laegemiddelstyrelsen |
The Danish Medicines Agency, an agency under the . It is the agency’s aim that medicinal products used in Denmark are of satisfactory quality, are safe to use and that they have the desired effect. The agency does so by administering the Danish legislation on:
- medicinal products
- reimbursement
- pharmacies
- medical devices
- euphoriants
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Visit the (http://www.laegemiddelstyrelsen.dk/) |
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FDA |
U.S Food and Drug Administration is the US Ministry for Food and Drug Administration. FDA approves, monitors and controls the producers in the regulated industry, amongst others in the areas of drugs, food and medical devices.
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Visit the (http://www.fda.gov/) |
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| ISPE |
ISPE - International Society for Pharmaceutical Engineering, a global organisation providing well-approved guidelines, training and technical publications for professionals in the pharmaceutical industry.
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Visit the (http://www.ispe.org/index.ww) |
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| EMEA |
EMEA - European Medicines Agency, a decentralised organisation in the European Community (EC).
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Visit the (http://www.emea.eu.int/) |
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| PDA |
Parenteral Drug Association, a global association for the advancement of the science and technology of pharmaceutical, biopharmaceutical and related products.
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Visit the (http://www.pda.org/) |
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| EudraLex |
The EC regulatory complex and administration. The organization approves, monitors and controls the producers in the areas of drugs and medical devices.
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Visit the (http://pharmacos.eudra.org/F2/home.html) |
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| ICH |
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
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Visit the (http://www.ich.org/) |
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| Article about QAtor |
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Article about QAtor published in Børsen May 2006
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Author
Louise Wendt Jensen
Published
Børsen May 2006 |
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| Presentation on Change Control and Configuration Management |
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ISPE, Los Angeles 2005, Chapter: Presentation on Change Control and Configuration Management
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Author
Jerry Anderson, ISPE
Published
May 2005 |
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| Article on Change Control and Configuration Management |
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Article on Change Control and Configuration Management
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Author
Bob McDowall
Published
August 2005 |
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| Free Book on Change Control and Configuration Management |
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Free Book on Change Control and Configuration Management
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Author
Don Jones, Realtimepublishers.com
Published
2004 |
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