Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier 2014

This 3-day course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application, and will show you how to compile this important part of your submission dossier. The course sessions will also examine the impact of the Common Technical Document. This course will teach you how to:

. Build Module 3 (CTD) of the dossier
. Know the legal framework and guidelines
. Meet the legal responsibilities of the manufacturing authorisation holder
. Write the application
. Define the impact of the Common Technical Document
. Write variation submissions for Europe
. Structure your submission teams
. Link your dossier requirements to GMP
. Minimise delays in your submission
. Use certificate of suitability as replacement of data

Price:
Book before the 25th April 2014: £1,795.00 + (VAT @ 20.00%) = £2,154.00
Book after the 25th April 2014: £1,895.00 + (VAT @ 20.00%) = £2,274.00