White papers

Download a complimentary white paper written by a FMD K&L professional
  • Artificial Intelligence for Quantitative Signal Detection Methods in Pharmacovigilance and Drug Safety

    Signal detection and risk management is an important area for pharmaceutical companies for safety surveillance and benefit-risk monitoring of approved products. Marketing Authorization Holders (MAH) are using various signal detection methods and systematic empirical assessments (i.e. quantitative methods) to identify signals.

    Download

  • A Practical Risk-Based Approach to Computerized System Validation

    Computerized System Validation (CSV) is a process of achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by the adaptation of principles, approaches and life cycle activities within the framework of validation plans and reports & by the application of appropriate operation controls throughout the lifecycle of the system.

    Download

  • EU MDR transition – how does it impact your organization

    This whitepaper highlights the key EU MDR regulatory changes with what organizations may need to know to ensure they are prepared and compliant with these regulations.

    Download

     

  • Preparing FDA Submission Data Packages


    Dhiren Patel

    Yuguang Zhao

    M.S., Senior Vice President, Programming and Development

    Tiepu Liu

    M.D., Ph.D., President, Global Biometrics

    The implementation of electronic data standards advances FDA efforts by enabling more timely and effective regulatory reviews of submissions and their corresponding data. This white paper describes the evolution of relevant standards and provides recommendations for best practices in planning and preparing FDA submission data packages.

    Download

  • 3 steps to outsource your drug safety program

    Alok

    Alok Gokhale

    MS, MPharm, Business Analyst

    Selecting a vendor to operate your safety program can be a daunting task. This white paper provides a stepwise procedure for choosing among the hundreds of available outsourcing partners.

    Download

  • Risk Management Roadmap to REMS Success

    Munendra

    John D. Balian

    M.D., Board of Directors

    At the birth of the REMS era, FMD K&L Board Director John D. Balian, M.D. and colleagues outlined a vision for anticipating risk-management requirements, establishing risk-management practices, and leveraging these techniques in the effective utilization of REMS programs. Their approach to enhancing product development, approval and commercialization remain germane to optimizing safety benefits for patients to this day.

    Download