Agenda

Day 1 Apr 23, 2018

8:30 AM — 12:00 PM

Course 1: EU Inspections and Audit Readiness Plans

1:00 PM — 5:00 PM

Course 2: Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

Day 2 Apr 24, 2018

7:00 AM — 7:45 AM

Continental Breakfast in the Exhibit Hall

7:00 AM — 5:15 PM

Registration

7:45 AM — 8:00 AM

Welcome and Opening Remarks

8:00 AM — 8:30 AM

Late-Breaking Presentation: Will Brexit Impact the Business of Life Science Companies in the EU?

8:30 AM — 10:30 AM

Session 1: Updated Global Regulations and Guidances (Including Canada and Australia)

10:30 AM — 11:00 AM

Refreshments, Exhibits, and Networking Break

11:00 AM — 12:30 PM

Session 2: EU Labeling Updates

12:30 PM — 1:45 PM

Luncheon, Exhibits, and Networking

1:45 PM — 3:15 PM

Session 3: US Updates

3:15 PM — 3:45 PM

Refreshments, Exhibits, and Networking

3:45 PM — 5:15 PM

Session 4: Japan and Asia Updates

5:15 PM — 6:15 PM

Networking Reception

Day 3 Apr 25, 2018

7:00 AM — 8:00 AM

Continental Breakfast, Exhibits, and Networking

7:00 AM — 3:45 PM

Registration

8:00 AM — 8:05 AM

Opening Remarks

8:05 AM — 9:30 AM

Session 5: Latin America, Middle East, and Africa Labeling Updates

9:30 AM — 11:00 AM

Session 6: Impact of EU GVP Module IX on Global Labeling Goverance

11:00 AM — 11:30 AM

Refreshments, Exhibits, and Networking Break

11:30 AM — 1:00 PM

Session 7: Combination Products and Medical Device Labeling

1:00 PM — 2:00 PM

Luncheon, Exhibits, and Networking

2:00 PM — 3:30 PM

Session 8: Labeling Process, Document Management Systems, and Databases

3:30 PM — 3:45 PM

Wrap-up

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Global Labeling Conference

Agenda

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