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Main Conference Day Two


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Travis Tibbetts

Global Distribution Manager
Pacira Pharmaceuticals
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Denise Valentino

Director, Global Trade Compliance and Logistics
Neurocrine Biosciences
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Daniela Vernille

Director of Temperature Control Logistics and Operational Compliance
Pfizer

Keynote

9:45 AM - 10:30 AM Reaching the 5th Child: How Technological Innovation & Industry Collaboration are Delivering Life Saving Vaccines to Children in Underdeveloped Nations

Harvey Rubin, Professor of Medicine, Microbiology and Computer Science and Founder & Director, University of Pennsylvania and Energize the Chain

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Harvey Rubin

Professor of Medicine, Microbiology and Computer Science and Founder & Director
University of Pennsylvania and Energize the Chain

11:15 AM - 12:00 PM Preparing for Brexit Effects on the EU GDP Requirements and What it Means for your Global Supply Chain

Franck Toussaint, Managing Director & Executive Director, BioLog Europe, BSMA Europe

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Franck Toussaint

Managing Director & Executive Director
BioLog Europe, BSMA Europe

12:00 PM - 12:45 PM Product Launch Efficiency: Collaboration Between Clinical, Commercial & Regulatory to Ensure Temperature Controlled Product Quality from Bench to Bedside

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Table 1- Global GDP Discussion
Table 2- Defining Roles & Responsibilities in a Siloed Organization
Table 3- Validating Packaging in the Last Mile
Table 4- Complying with Global Regulations for CRT Products

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Bruce Ginn

Senior Director of Supply Chain and Operations
Cerus Corp
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Daniela Vernille

Director of Temperature Control Logistics and Operational Compliance
Pfizer

Track B- Clinical Trial Logistics

1:50 PM - 2:30 PM Utilizing Simulation Tools for Supply Planning and Demand Forecasting to Ensure On-time Delivery with Minimal Scrap

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Track C- Pharma Traceability

1:50 PM - 2:30 PM Defining Operational Requirements For the Flow and Evaluation of ‘Exception” Handling Post Integration

Table 1- Regulatory Audits
Table 2- Shipping Between Temperature Extremes
Table 3- Emerging Market Infrastructure Challenges
Table 4- Shipping Outside of Label Claims

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Lou Sehl

Executive Director, Manufacturing and Technical Operations
MyoKardia
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Matthew Parker

Associate Director, Materials
Nektar Therapeutics

Track B- Clinical Trial Logistics

2:40 PM - 3:20 PM CASE STUDY: Advantages and Disadvantages of Phase Change Materials in Single Use and Reusable Containers for Transportation

Track C- Pharma Traceability

2:40 PM - 3:20 PM PANEL DISCUSSION: Partnering with the Right Partner: Addressing Complexities that Could Occur When Solidifying the Right Partner for Your Serialization Needs

Track A- Cold Chain

3:55 PM - 4:40 PM CASE STUDY: End-to-end Process Excellence to Ensure Uninterrupted Delivery & Minimize Risk

Eugenio Filippi, Associate Director Plasma Logistics & Analytics, Shire

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Eugenio Filippi

Associate Director Plasma Logistics & Analytics
Shire

Track B- Clinical Trial Logistics

3:55 PM - 4:40 PM Qualification of Thermal Shipping Systems to Meet Global Health Authority Requirements

Myriam Antoun, Director, Global Regulatory Affairs, PPD

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Myriam Antoun

Director, Global Regulatory Affairs
PPD

4:40 PM - 5:25 PM PANEL DISCUSSION- How the Industry can Collaborate to Create Standards & Methods for Cold Chain

Franck Toussaint, Managing Director & Executive Director, BioLog Europe, BSMA Europe

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Franck Toussaint

Managing Director & Executive Director
BioLog Europe, BSMA Europe