Guide to EU pharmaceutical regulatory law
By: edited by Sally Shorthose
Publisher: Kluwer Law International; Sold and distributed in North, Central and South America by Aspen Publishers
Published: 2010
Place of publication: Alphen aan den Rijn, The Netherlands; Frederick, MD
Language: eng
Number of pages: 672
ISBN-13: 9789041128454
Other titles: Guide to European Union pharmaceutical regulatory law
Notes: Includes bibliographical references and index.
Table of contents: title: Overview of european pharmaceutical regulatory requirements / Sally Shorthose & Mary Smilie; title: Obtaining a marketing authorisation / Sally Shorthose & Mary Smilie; title: Pharmacovigilance / Mary Smilie & Gina Brueton; title: Clinical trials / Sally Shorthose; title: Obtaining a marketing authorisation : abridged procedure / Machteld Hiemstra; title: Conditional marketing authorisations / Sally Shorthose & Victoria Evans; title: Variations to marketing authorisations / Lorna Brazell; title: Paediatrics / Sally Shorthose & Victoria Evans; title: Combination products / Philipp Neels; title: Biologicals / Victoria Evans; title: Orphan drug protection / Victoria Evans; title: Homeopathic, herbal, and traditional herbal medicinal products / Colette Mulder; title: Medical devices / Ulf Grundmann & Jarste Akkermann; title: Parallel trade / Ina vom Feld & Philipp Neels; title: Competition law in the pharmaceutical sector / Morten Nissen, Geoffroy van de Walle de Ghelcke & Melanie Vilarasau; title: Advertising medicinal products for human use / Mary Smillie ... [et al.].