Biopharmaceutical Good Distribution Practices Summit Presentations

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Monday, March 18, 2013 – Pre-conference Workshop

Developing a Controlled Environment Logistics Validation Master Plan
Gary Hutchinson, President, Modality Solutions LLC, formerly Director of Global Transportation, Amgen (Co-Chair)

Tuesday, March 19, 2013 – Summit Day 1

You Are Your Brand, Your Brand Is You — Combating Counterfeiting
B. Brett Heavner, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Industry Update — Why Rx-360's New Initiatives Could Change The Way You Operate
Ash Patel, Associate Director, Product Security & Brand Integrity, Biogen Idec

Stability Testing to Support Distribution of New Drug Products
Rebecca Gentile, Senior Specialist, Quality, Global Vaccine & Biological Stability, Merck

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
Stephen Healy, European Sales Director, Intelsius

Cubist Pharmaceutical Case Study: Managing a Virtual Supply Chain
Michele Johnson, Supply Chain Advisor, Cubist Pharmaceuticals (Co-Chair)

Good Distribution Practice Quality Agreements — Can’t We Just All Get Along? Understanding Where Industry Has Consensus and Differences
Kim Egan, Founder, Saltbox Consulting, formerly Partner, Co-Chair Health Care Sector, Co-Chair, Clinical Trials Working Group, DLA Piper LLP

Wednesday, March 20, 2013 – Summit Day 2

A Regulator Dissects Current Track-and-Trace Strategies
Kim Egan, Founder, Saltbox Consulting, formerly Partner, Co-Chair Health Care Sector, Co-Chair, Clinical Trials Working Group, DLA Piper LLP

Packaging As the First Line of Defense Against Counterfeiting
Ash Patel, Associate Director, Product Security & Brand Integrity, Biogen Idec