THE EU
PHARMACEUTICAL
DOSSIER

Conference Date: 27-28 Nov 2008
Conference Ref: A11-6208
Venue: Hotel Majestic Barcelona, Spain

COST £1,280 (No VAT is applicable for this meeting)

The conference will provide a wide-ranging, up-to-date coverage of the pharmaceutical issues that underpin a successful marketing authorisation application. In a carefully-structured programme, delegates will learn about the key components of the EU licensing systems for substances for pharmaceutical use and for finished medicinal products. Delegates will learn about sources of official information and expert guidelines and will find out how to prepare the ‘Quality’ parts of the CTD(in Modules 1.3, 2.3 and 3).

Information will also be given on common deficiencies in the pharmaceutical dossier. It is anticipated that the course will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.

All the speakers have had many year’s experience working in or for the UK regulatory authorities and also for various other bodies with multi-national regulatory activities. There will be ample opportunity for question and answer sessions throughout the two days of the course, further to enhance the delegates’ understanding of pharmaceutical issues of individual concern.