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#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1

Nov 16 2014 9:00AM - Nov 16 2014 10:30AM | Tokyo Big Sight 3-11-1 Ariake Koto-ku Tokyo 135-0063 Japan

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Overview 

Since 2012, EU health authorities have issued a series of guidelines detailing their expectations on performance of pharmacovigilance for medicinal products in the European Union. This session will present those requirements affecting safety-labeling decision-making as part of the pharmacovigilance activities and explain, how the EU expectations will influence the design of the Global Labeling Process as well as the maintenance of Company Core Data Sheets in globally acting companies.

Contact Information 

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAJapan@diajapan.org
www.diajapan.org

Instructor(s) 

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