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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Modernization and Harmonization of Inspectional Approaches

    Session Chair(s)
      Stephen  Mahoney, JD, MS

      Stephen Mahoney, JD, MS

      • Senior Director, Compliance and External Collaboration, Pharma Technical Quality
      • 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  Sklamberg, JD, MA

      Reforming FDA's Enforcement Process

      Howard Sklamberg, JD, MA

      • Partner, Health Group
      • Akin Gump Strauss Hauer & Feld LLP, United States
      Thomas J. Cosgrove, JD

      International Inspections Issues and Successful Remediation

      Thomas J. Cosgrove, JD

      • Partner
      • Covington & Burling LLP, United States