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Bücher Wissen & Bildung Englische Bücher Naturwissenschaft, Medizin, Informatik, Technik Medizin Pharmazie Improving the Regulatory Review Process: Assessing Performance and Setting Targets
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets
(Broschiert, Englisch)
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Beschreibung
At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different… authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance. The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process. Dieses Produkt haben wir gerade leider nicht auf Lager.
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Technische Daten
Erscheinungsdatum
05.11.2012
Sprache
Englisch
EAN
9789401060424
Herausgeber
Springer Netherland
Serien- oder Bandtitel
Centre for Medicines Research Workshop
Sonderedition
Nein
Seitenanzahl
163
Auflage
1
Einbandart
Broschiert
Schlagwörter
assessment, drug, drug development, efficiency, research
Thema-Inhalt
MKG - Pharmakologie
LNTM - Recht des Gesundheitswesens und Medizinrecht
MBN - Public Health und Präventivmedizin
Höhe
240 mm
Breite
16 cm
Hersteller: Springer Nature Customer Service Center GmbH, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com
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