ExpertFORUM Labelling Update 2013

Organization: FORUM Institut für Management GmbH

Venue: Pullman Cologne

Location: Cologne, Germany

Event Date/Time: May 06, 2013 / 9:00 am - (GMT +1:00 hours) End Date/Time: May 07, 2013 / 5:00 pm - (GMT +1:00 hours)
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This ExpertFORUM summarises the current and upcoming requirements for the package leaflet, the outer package and the SmPC. - Which new requirements have arisen as a result of the pharmacovigilance legislation? - Which kind of initiatives can be expected from the EU Commission in terms of readability? - How can product information be made better accessible to patients, doctors.?

May I invite you to a detailed exchange with experts from the industry and various European agencies? Day two goes into the practical processing of safety data into product labelling. How important are a well-designed global labelling system and its core document, the Company Core Data Sheet? A highly experienced workshop leader will guide you through the safety sections of the CCDS as well as through all process aspects that you need to consider for your daily practice.

Topics: - Readability update: initiatives from the EU commission - Codes, symbols and pictograms on the outer package - Safety labelling - impact of the new pharmacovigilance legislation - Harmonisation of the core safety information - Product information and social media

This conference and workshop address the needs of coworkers in the pharmaceutical industry working in the field of product information.

Especially those working in the following departments will benefit from this event: - Regulatory Affairs - Labelling/Artworks - Medical Affairs - Pharmacovigilance


Helenenstr. 14


FORUM Institut für Management GmbH