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DIA 2018 Global Annual Meeting


Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions

    Session Chair(s)
      Kent  Cochran, MS

      Kent Cochran, MS

      • Director, Regulatory Medical Writing
      • Janssen Pharmaceutical Companies of Johnson & Johnson, United States
    Medical writers are under increased pressure to produce submission documents within very short timelines. Complications include too many reviewers, senior management reviews coming in late in the process, and multiple additional analyses resulting in new tables and figures. This session will highlight strategies that are within the sphere of influence of the medical writer.
    Learning Objective : Describe a proposed model for preparing the Clinical components of Core Dossiers for marketed products, and discuss the short- and long-term resource demands on Clinical functions to sustain such a model.
    Speaker(s)
      Kent  Cochran, MS

      Accelerated Submissions: Influencing Skills and Strategies for Medical Writers

      Kent Cochran, MS

      • Director, Regulatory Medical Writing
      • Janssen Pharmaceutical Companies of Johnson & Johnson, United States
      Nancy R. Katz, PhD

      Revisiting Section 2.7.4, Summary of Clinical Safety

      Nancy R. Katz, PhD

      • President and Principal, Medical Writing
      • Illyria Consulting Group, Inc., United States
      Michael  Hoffman, DrSc

      Clinical Core Dossier: A Sustainable Model to Expedite Market Expansion?

      Michael Hoffman, DrSc

      • Head of Clinical Scientific Writing
      • Shire Pharmaceuticals, United States