10th Conference on Marketing Authorisation

Organization: FORUM Institut für Management GmbH

Venue: Pullman Cologne

Location: Cologne, Germany

Event Date/Time: Sep 30, 2013 / 9:00 am - (GMT +1:00 hours)
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Description

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.

Venue

Helenenstr. 14
Cologne
Germany
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Organizations

FORUM Institut für Management GmbH