During this course you will get to know the relevant aspects of applying for and maintaining a marketing authorisation in the ICH countries.
You will learn what you need to know from a GMP perspective about
the basic requirements for drug approval in Europe, the US and Japan
the structure of the marketing authorisation dossier according to the CTD
the input from the GMP regulated Departments
drug approval procedures in the EU and US
documents to be provided and timelines to be observed
how to handle changes and variations in the EU, the US and Japan
Background
For getting a drug approved it is required to demonstrate its quality, efficiency and safety. For that purpose the format of the Common Technical Document (CTD), which is mandatory in Europe since more than 10 years now, has to be used. It is also used to apply for a marketing authorisation in the US and Japan. Therefore, a good understanding of the CTD structure is inevitable and a basic requirement for all persons from GMP regulated departments involved in providing and compiling documents for a marketing authorisation application.
For the maintenance of a marketing authorisation it is very important to know how to handle all the changes and variations occurring during the life cycle of a medicinal product. The rules for handling variations in Europe are laid down in the variations regulation (EC) No. 1234/2008 – being applicable as well for national marketing authorisations from August 3rd 2013 – and supporting guidelines. For handling changes in the US rules are provided in different guidances for industry and for approval of changes in Japan there are specific procedures in place to be followed. Maintaining marketing authorisations in a global scenario is a challenge and requires strategic planning and a good knowledge of the different regulations and timelines. Efficient and smooth communication between GMP and Regulatory Affairs is a key factor of success.
Target Group
This education course is designed for all persons involved in the compilation of pharmaceutical dossiers for global marketing authorisations in the EU and USA. Furthermore the course will be of interest to personnel from Regulatory Affairs, Quality Assurance, Quality Control and Production and Project Management.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF