Improving the Regulatory Review Process

Name: Improving the Regulatory Review Process
Brand: Springer
SKU: 9789401072977
Price: 58863 HUF
Availability: InStock

Industry and Regulatory Initiatives

Szerző: C. Lumley, S. R. Walker

Nyelv:

Kötés: Puha kötésű

Kiadó: Springer

Elérhetőség: Beszállítói készleten

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Regulatory review is the last major development hurdle that must be passed by a new medicine before...

Információk a könyvről

Szerző

C. Lumley, S. R. Walker

Nyelv

Angol

Kötés

Könyv - Puha kötésű

Kiadva

2011

oldal

172

EAN

9789401072977

ISBN

9401072973

Enbook ID

06971932

Kiadó

Springer

Súly

306

Méretek

155 x 235 x 11

Teljes leírás

Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.

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Improving the Regulatory Review Process

Industry and Regulatory Initiatives

Információk a könyvről

Teljes leírás

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Azok a vásárlók, akik ezt a könyvet megvásárolták, a következőket is megvásárolták