Marketing Authorisation Outside the ICH Region

Aims and objectives:
Getting ready for business on international markets, including those in the non-ICH region? Then you shouldn't miss out on this seminar.

Here you will get practical tips on which regions/countries enforce which requirements and where you might want to seek external help in regulatory affairs questions.

After having attended this seminar you will be able to define your regulatory strategy and have a deeper knowledge on the current challenges in the various regions of the world.


This seminar addresses the needs of regulatory affairs professionals with marketing authorisations outside the
EU or aiming for new marketing authorisations worldwide.

It is also useful for business development, clinical affairs and medical affairs professionals.
A working knowledge of the European marketing authorisation system is assumed.

Topics
- Who follows the ICH or WHO principles?
- Submission strategy based on CPP?
- Role of affiliates, external consultants and agents
- Dossier, submission and maintenance duties
- Rolling out submissions