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Concept Heidelberg
Tel: +[49] 62 21/84 44 0
Fax: +[49] 62 21/84 44 84

Email: neth@concept-heidelberg.de

Marketing Authorisation Procedures in the EU and the US

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Date: 16th - 19th October, 2012

Location: Munich, Germany

Summary:
Pharmaceutical - Training

During these courses you will get to know the relevant aspects of marketing authorisation procedures in Europe and USA. You will learn about the basic requirements to get drug approved in Europe and the US the structure of the marketing authorisation dossier according to the CTD the peculiarities of the Drug Master File Procedure for drug approval in the US handling changes and variations in the EU and the USA.

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EMD Millipore Food Safety Solutions