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DIA 2018 Global Annual Meeting


Pharmacovigilance: No Longer Going it Alone

    Session Chair(s)
      Alan M. Hochberg

      Alan M. Hochberg

      • Scientific Enablement Leader
      • F. Hoffmann-La Roche Ltd., Switzerland
    In the past, pharmacovigilance departments have often been limited in the way they interact with other functions within pharmaceutical organizations. The traditional function of the Safety organization has been to prevent harm to patients, and to react to emerging evidence of potential harm. Thus we have been reactive rather than proactive, and tactical rather than strategic.This is now changing. The growing emphasis on health technology assessment in the health care field requires strategic contributions from Safety. And expectations of a more patient-centered approach now mean that we must help patients manage their adverse drug reactions, in addition to simply characterizing and communicating risks. This session will describe how this transformation is taking place, resulting in a Safety organization that is a full strategic partner in development, and a key supporting function for commercialization. Strong, cross-functional safety governance is essential for effective decision making; means for assessing and improving safety governance maturity will be presented.

    The session will also describe the evolving role of the safety statistician in helping multidisciplinary safety teams to think more quantitatively, and to improve the conversations we are having about safety evaluation during drug development.
    Learning Objective : Upon completion of the presentation participants will be able to: • Apply maturity model concepts to their safety governance model • Determine the stage of maturity in their organization
    Speaker(s)
      Alan M. Hochberg

      Evolving the Strategic Framework for the Safety Department

      Alan M. Hochberg

      • Scientific Enablement Leader
      • F. Hoffmann-La Roche Ltd., Switzerland
      Ellenie  Nichols, MEd

      Building Better Governance: The Maturity of Safety Governance Models and Considerations for Organizations

      Ellenie Nichols, MEd

      • Global Patient Safety and Labeling, Safety Governance Lead
      • Amgen Inc., United States
      Amit  Bhattacharyya, PhD

      Multi-Disciplinary Approach for Successful Collaboration: Improving Conversations to Achieve Impact in Drug Development

      Amit Bhattacharyya, PhD

      • Vice President, Biometrics
      • ACI Clinical, United States