European Union

Content by Geography - European Union

  • Optimizing Clinical Trials To Support Marketing Approval Of Biosimilars

    Optimizing Clinical Trials To Support Marketing Approval Of Biosimilars

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  • How to Right-Size Quality and GCMP Compliance Investments

    How to Right-Size Quality and GCMP Compliance Investments

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  • Five Ways to Manage Data Integrity Risks When Using Foreign CMOs

    Five Ways to Manage Data Integrity Risks When Using Foreign CMOs

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  • Case Study: Vaccine Production - Batch verification and associated GMP documentation

    Case Study: Vaccine Production - Batch verification and associated GMP documentation

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  • FDA Inspectional Observations 483s Infographic

    FDA Inspectional Observations 483s Infographic

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  • The Art of Submission Approvals

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  • GDUFA II Gifts "Complex" Generics With Accelerated Pathways Perks

    GDUFA II Gifts "Complex" Generics With Accelerated Pathways Perks

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  • Quality By Design Case Study

    Quality By Design Case Study

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  • Europe Braces for Brexit

    Europe Braces for Brexit

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  • Brexit-The Story So Far

    Brexit-The Story So Far

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  • Case Study: Data Integrity Assessment

    Case Study: Data Integrity Assessment

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  • Case Study: Data Verification - Method Verification and Comparability

    Case Study: Data Verification - Method Verification and Comparability

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  • Case Study: Deviation Management

    Case Study: Deviation Management

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  • Mitigate The Risk Of Data Integrity Issues

    Learn How Here
  • Recalibrating U.S. and E.U. Regulatory Strategies To Leverage Accelerated Pathways

    Recalibrating U.S. and E.U. Regulatory Strategies To Leverage Accelerated Pathways

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  • PDUFA VI Guide: Interpretation, Strategy & Implementation

    PDUFA VI Guide: Interpretation, Strategy & Implementation

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  • Product Innovation, Regulatory Reforms And Accelerated Pathways in the Asia-Pacific Region

    Product Innovation, Regulatory Reforms And Accelerated Pathways in the Asia-Pacific Region

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  • Webinar: You Have To Anyway! How and Why to Leverage IDMP Compliance1:00:12

    Webinar: You Have To Anyway! How and Why to Leverage IDMP Compliance

    IDMP Compliance webinar delivered Dec. 6, 2016

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  • Podcast: 5 ways to Prevent Data Integrity Mistakes

    Podcast: 5 ways to Prevent Data Integrity Mistakes

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  • Strategies to Reduce Phase III Failure Rates

    Strategies to Reduce Phase III Failure Rates

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  • Podcast: 5 ways to Detect Data Integrity Mistakes

    Podcast: 5 ways to Detect Data Integrity Mistakes

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  • De-Silo Development

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  • 5 Ways to Streamline Biosimilar Development

    5 Ways to Streamline Biosimilar Development

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