• Operational Excellence – A Win/Win for Supplier Collaboration

    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,…

  • Setting Up an FDA-Compliant Data Integrity Program

    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

  • FDA Inspection Trends

    FDA Inspection Trends

    Michael Klapal, Drug Specialist - U.S. FDA || October 1, 2014
    Topics: • Quality Agreements • Inspection Trends • Field Alert Reporting Trends…

  • Sponsor Strategies to Optimize R&D Outsourcing

    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…

  • The Outlook for the CMO Industry

    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…

  • 10 Steps to a Collaborative Outsourcing Partnership

    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…

  • Assuring Quality from CMO’s

    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

  • Drafting the Perfect Contract

    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…

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