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Guide to EU pharmaceutical regulatory law

Author: Sally Shorthose
Publisher: Alphen aan den Rijn, The Netherlands : Kluwer Law International ; Frederick, MD : Sold and distributed in North, Central and South America by Aspen Publishers, ©2010.
Edition/Format:   Print book : EnglishView all editions and formats
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Document Type: Book
All Authors / Contributors: Sally Shorthose
ISBN: 9789041128454 904112845X
OCLC Number: 657271183
Notes: 2nd ed.- cataloged as a serial in LC.
Description: lvi, 672 pages ; 25 cm
Contents: 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 [and others].
Other Titles: Guide to European Union pharmaceutical regulatory law
Responsibility: edited by Sally Shorthose.

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