Marketing Authorisation Procedures in the EU and the US 19-21 October 2010 Barcelona, Spain Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 2580,--) Book this option: ECA Members (EUR 2320,--) Book this option: EU GMP Inspectorates (EUR 1290,--) Book this option: APIC Members (does not include ECA membership) (EUR 2490,--)
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 Background Before a drug can be marketed it is required to demonstrate its quality, efficiency and safety. In Europe there are the following procedures for getting a marketing authorisation for a medicinal product: the national procedure, the decentralised procedure, the centralised procedure and the mutual recognition procedure. Since 1 July 2003 the CTD (Common Technical Document) is the mandatory format for the dossier and has to be used for all marketing authorisation procedures in Europe. On 24 November 2008 the new variations regulation Directive (EC) No. 1234/2008 was published and two other guidelines which describe the details of the various categories of variations have been created by the EMEA. This new regulation will apply from 1 January 2010 and will be binding and directly applicable in all EU member states. For dossier submissions in the US the CTD is not mandatory but it is highly recommended to use it as it is the preferred format for dossiers. In general it is important to be familiar with the laws and guidelines relevant for getting drugs approved in the US. In particular the requirements for CMC dossier have to be watched narrowly. Moreover the US Drug Master File Procedure is different from the respective procedures in Europe and should be well understood. The same applies to the rules for handling changes and variations. Dealing with changes in a way that a loss of time can be avoided is quite often a challenge for all departments involved Target Group These education courses are designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations in the EU and USA. Furthermore the courses will be of interest to personnel from Regulatory Affairs, Quality Assurance, Quality Control and Production.