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DIA 2018 Global Annual Meeting

Modernization and Harmonizationof Inspectional Approaches

    Session Chair(s)
      Joseph C. Famulare

      Joseph C. Famulare

      • Vice President, Global Compliance and External Collaboration
      • Genentech, A Member of the Roche Group, United States
    This session will discuss industry challenges, needs and feedback regarding international efforts currently underway to harmonize global inspection schemes.
    Learning Objective : The forum will discuss the need to engage FDA in reforming its compliance and enforcement process.
      Vivianne  Arencibia

      Moving Beyond Compliance

      Vivianne Arencibia

      • Global Vice President, Head External Relations
      • Novartis Pharmaceuticals Corporation, United States
      Howard R. Sklamberg, JD, MA

      Reforming FDA's Enforcement Process

      Howard R. Sklamberg, JD, MA

      • Partner, Health Group
      • Akin Gump Strauss Hauer & Feld, LLP, United States