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Last Updated Saturday, October 25 2014
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Conference Sessions

Related Searches: CMO Outsourcing
Operational Excellence – A Win/Win for Supplier Collaboration
Sunil Ghogre, Team Leader Operational Excellence, Pfizer
October 1, 2014
We are innovating to bring therapies to patients that significantly improve their lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. We are On a mission to be the premier,…  Read More »
Setting Up an FDA-Compliant Data Integrity Program
John Avellanet, Cerulean Associates LLC
October 1, 2014
(What’s So Funny ‘Bout) Part 11 and Data Integrity  Read More »
FDA Inspection Trends
Michael Klapal, Drug Specialist - U.S. FDA
October 1, 2014
Topics: • Quality Agreements • Inspection Trends • Field Alert Reporting Trends…  Read More »
Sponsor Strategies to Optimize R&D Outsourcing
Mary Jo Lamberti, Tufts CSDD
October 1, 2014
Areas of Focus •Background and Overview of Outsourcing Research •Working Group Model and Overall Perceptions •Key Results of Working Group Data –Type of outsourcing relationship model(s) organizations have adopted –Functi…  Read More »
The Outlook for the CMO Industry
Jim Miller, President, PharmSource
October 1, 2014
Where is the CMO industry headed? • Drivers – Propensity to outsource – Formulary acceptance for new drugs – Industry consolidation • Outlook – Future depends on new approvals for small and mid-size compan…  Read More »
10 Steps to a Collaborative Outsourcing Partnership
Inigo Pfeiffer, PhD & Melissa Joseph, PhD, Senior Staff Scientist & Senior Director Pharmaceutical Development, Targacept
October 1, 2014
Outline: •Identifying a Partnership •Setting up the Partnership •Maintaining and growing the Partnership…  Read More »
Assuring Quality from CMO’s
Dr. Kevin Siver, PhD, Onyx Pharmaceuticals
October 1, 2014
Serving Patients is a Privilege. This Privilege Comes with Significant Responsibilities  Read More »
Drafting the Perfect Contract
Brian North & Mark Yacura, Buchanan, Ingersoll & Rooney PC
October 1, 2014
Contract Manufacturing Agreements:  - A well drafted contract can reduce potential for liability, disputes and litigation  - Use of term sheets  - Value of contract templates…  Read More »

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