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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

Agenda

7:15 AM — 8:15 AM

Registration and Continental Breakfast

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 10:00 AM

Session 1 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Understanding the Issues

10:00 AM — 10:30 AM

Networking, Exhibits, and Refreshment Break

10:30 AM — 12:00 PM

Session 2 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Strategies for Industry

12:00 PM — 1:30 PM

Luncheon

1:30 PM — 3:00 PM

Session 3 - Tracking from Signal to Package

3:00 PM — 4:00 PM

Networking, Exhibits, and Refreshment Break

4:00 PM — 5:30 PM

Session 4 - From Labeling (Global and Local) Through Dossier Content Using XML - Extending the Value of Structured Content Management and Reuse

5:30 PM — 6:30 PM

Reception

7:30 AM — 8:00 AM

Registration and Continental Breakfast

8:00 AM — 9:30 AM

Session 5 - Methods for Reducing Medication Errors

9:30 AM — 10:00 AM

Networking, Exhibits, and Refreshment Break

10:00 AM — 10:30 AM

Sessioin 6 - Recent Updates in EU Labeling

10:30 AM — 11:30 AM

Session 7 - Hot Topics in Canada

11:30 AM — 12:30 PM

Luncheon

12:30 PM — 2:00 PM

Session 8 - Labeling in Asia

2:00 PM — 2:30 PM

Networking, Exhibits, and Refreshment Break

2:30 PM — 4:30 PM

Session 9 - FDA Labeling Update

4:30 PM — 4:45 PM

Closing Remarks

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