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Bethesda North Marriott Hotel and Conference Center

Apr 09, 2014 7:00 AM - Apr 10, 2014 5:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling 2014: Compliance in a Changing Regulatory Environment

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Sessioin 6 - Recent Updates in EU Labeling

Session Chair(s)

Megann Looker

Megann Looker

Executive Director, Head of Global Labeling

Jazz Pharmaceuticals, United Kingdom

This session will discuss the new developments in labeling that have taken place in the last 12 months in the EU. Topics of discussion include: the impact of the Pharmacovigilance Legislation (March 2013), including additional monitoring and the Black Symbol; increased encouragement to report ADRs; and QRD v9. Revisions to the EU Guideline on the packaging of medicinal products in the EU (July 2013) and the EC Report on the Shortcomings of Product Information in the EU (Jan 2014) will also be discussed.

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