• Some Practical Considerations for Implementing Serialization

    Some Practical Considerations for Implementing Serialization

    Kurt Wieditz, Global Serialization PMO, Pfizer, External Supply Operating Unit September 22, 2015
    || Debunking some common serialization myths: • History and Compliance Timelines • Infrastructure • Governance • Serialization Impacts • Cost / Value Proposition • Business as Usual…

  • Inspection Trends

    Inspection Trends

    Douglas Kovacs, Supervisory Investgator, FDA New Jersey District September 22, 2015
    || Top 10 Citations for FY 2014: • Based on 645 FDA 483 observations issued for FY 2014 • Does not include FDA 483’s manually prepared outside of Turbo EIR (i.e. API inspections) • Includes the percentage the citation was issue…

  • Best Practices in Supplier Quality Management

    Best Practices in Supplier Quality Management

    Linda Evans O Connor, Director, Lachman Consultants September 22, 2015
    || The pharmaceutical quality system, including the management responsibiliAes described in this section, extends to the control and review of any outsourced activities and quality of purchased materials.…

  • CMO Industry Update

    CMO Industry Update

    Jim Miller, Founder and President, PharmSource Information Services September 22, 2015
    || Presentation: • Dose CMO industry size and growth • Growth drivers • Mitigating factors • Industry outlook Key Points: • Robust recent growth in CMO industry • Strong tailwinds driving industry • Headw…

  • Keeping a Culture of Quality and Compliance in Tight Economic Times

    Keeping a Culture of Quality and Compliance in Tight Economic Times

    John Avellanet, Founder and Principal, Cerulean Associates LLC September 22, 2015
    || Agenda: true cost of being compliant five sustaining steps to lean quality…

  • The Potential Impact of Biosimilars on Biomanufacturing Capacity

    The Potential Impact of Biosimilars on Biomanufacturing Capacity

    Dawn M. Ecker, Consultant, BioProcess Technology Consultants, Inc. September 22, 2015
    || Outline: Current global biopharmaceutical capacity landscape: • Geographical distribution • Balance of supply and demand Biosimilar trends and pipeline: • Data from marketed products • Pipeline and forecasts Future gr…

  • External Capabilities Build in Drug Discovery: Experiences and Challenges in Global Outsourcing

    External Capabilities Build in Drug Discovery: Experiences and Challenges in Global Outsourcing

    Ajai K. Chaudhary, Ph.D., Director, Merk Research Laboratories September 22, 2015
    || Current Challenges: • Upcoming onslaught of expiring patents • Increasing demands from payers and third party providers to demonstrate differentiation (therapeutic, cost etc.) • More stringent regulatory requirement Given the eco…

  • 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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