Biopharmaceutical Good Distribution Practices Summit Agenda
Monday, March 18, 2013 – Pre-conference Workshop |
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12:00 p.m. – 1:00 p.m. |
Registration |
1:00 p.m. – 5:00 p.m. |
Developing a Controlled-Environment Logistics Validation Master Plan
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Tuesday, March 19, 2013 – Summit Day 1 |
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8:00 a.m. – 9:00 a.m. |
Registration and Continental Break |
9:00 a.m. – 9:15 p.m. |
Chairperson Welcoming Remarks, Gary Hutchinson, President, Modality Solutions LLC, formerly Director of Global Transportation, Amgen |
9:15 a.m. – 10:00 a.m. |
FDA’s Perspective on GDP: Harness and Harmonize Your Operations & Quality Teams
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10:00 a.m. – 10:45 a.m. |
Without True Distribution Validation Integrity, You're in for a World of (Global) Hurt
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10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 12:30 p.m |
Panel Discussion: Strengthening the Distribution Chain – How to Protect Your Product From Crooked Employees, Pirates, Warehouse Warriors and Other Miscreants
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12:30 p.m. – 1:30 p.m. |
Lunch Break |
1:30 p.m. – 2:15 p.m. |
Stability Testing to Support Distribution of New Drug Products
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2:15 p.m. – 3:00 p.m. |
Maybe the World Isn’t Coming to an End, But It Sure Seems Like That on Some Days — Contingency Planning Best Practices for Biopharmaceuticals GDPs
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3:00 p.m. – 3:45 p.m. |
You Are Your Brand, Your Brand Is You — Combating Counterfeiting
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3:45 p.m. – 4:30 p.m. |
Cubist Pharmaceutical Case Study: Managing a Virtual Supply Chain
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4:30 p.m. – 4:45 p.m. |
Refreshment Break |
4:45 p.m. – 6:00 p.m. |
Panel: Good Distribution Practice Quality Agreements — Can’t We Just All Get Along? Understanding Where Industry Has Consensus and Differences
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6:00 p.m. – 7:00 p.m. |
Adjournment and Networking Cocktail Reception |
Wednesday, March 20, 2013 – Summit Day 2 |
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8:00 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Chairperson Recap of Day One Highlights |
9:15 a.m. – 10:00 a.m. |
A Regulator Dissects Current Track-and-Trace Strategies
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10:00 a.m. – 10:45 a.m. |
Packaging As the First Line of Defense Against Counterfeiting
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10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 12:30 p.m. |
Panel: The Importance of Importation Security
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12:30 p.m. |
Event Conclusion |