书目详细信息
： Guide to EU pharmaceutical regulatory law /
书目信息 机读格式(MARC)
| ISBN： | 9789041128454 (pbk. : alk. paper) |
|---|---|
| ISBN： | 904112845X (pbk. : alk. paper) |
| 编目源： | DLC DLC |
| 地理区域代码： | e------ |
| 题名： | Guide to EU pharmaceutical regulatory law / edited by Sally Shorthose. |
| 索书号： | D950.21/S559E |
| 出版发行项： | Alphen aan den Rijn, The Netherlands : Frederick, MD : Kluwer Law International ; Sold and distributed in North, Central and South America by Aspen Publishers, c2010. |
| 载体形态： | lvi, 672 p. ; 25 cm. |
| 书目附注： | Includes bibliographical references and index. |
| 格式化内容附注： | Overview of european pharmaceutical regulatory requirements / Sally Shorthose & Mary Smilie -- Obtaining a marketing authorisation / Sally Shorthose & Mary Smilie -- Pharmacovigilance / Mary Smilie & Gina Brueton -- Clinical trials / Sally Shorthose -- Obtaining a marketing authorisation : abridged procedure / Machteld Hiemstra -- Conditional marketing authorisations / Sally Shorthose & Victoria Evans -- Variations to marketing authorisations / Lorna Brazell -- Paediatrics / Sally Shorthose & Victoria Evans -- Combination products / Philipp Neels -- Biologicals / Victoria Evans -- Orphan drug protection / Victoria Evans -- Homeopathic, herbal, and traditional herbal medicinal products / Colette Mulder -- Medical devices / Ulf Grundmann & Jarste Akkermann -- Parallel trade / Ina vom Feld & Philipp Neels -- Competition law in the pharmaceutical sector / Morten Nissen, Geoffroy van de Walle de Ghelcke & Melanie Vilarasau -- Advertising medicinal products for human use / Mary Smillie ... [et al.]. |