THE EU PHARMACEUTICAL DOSSIER - CTD MODULES 2.3 and 3
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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.
The speakers have had many years' 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 dele