10th Conference on Marketing Authorisation
Organization: FORUM Institut für Management GmbH
Venue: Pullman Cologne
|Event Date/Time: Sep 30, 2013 / 9:00 am - (GMT +1:00 hours)|
Now in its 10th year, this conference addresses the current and upcoming challenges in regulatory affairs in Europe. This year's focus lies on - the impact of the pharmacovigilance legislation on pre- and post-approval processes. - the reevaluation of the benefit-risk balance for established products - where do you have to especially take care of your marketed products? - publicly available information on your product - who benefits from all the available data? - rising quality expectations in the context of ICH Q8-Q11. - the inclusion of purely national variations under the variation regulation ...and much more.