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DIA 2018 Global Annual Meeting

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

Using Real World Evidence for Regulatory Support: Time to Embrace the Future

    Session Chair(s)
      Nancy A. Dreyer, DIAFellow, PhD, MPH, FISPE

      Nancy A. Dreyer, DIAFellow, PhD, MPH, FISPE

      • Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation
      • IQVIA, United States
    As mandated under the 21st Century Cures Act, in December 2018, the FDA is scheduled to issue a draft framework and guidance for evaluating real world evidence (RWE) to help support the approval of a new indication for an already approved drug, and to help support or satisfy post approval study requirements. This session will examine the latest FDA thinking and global experience in terms of decision support for label expansions and other regulatory decisions.
    Learning Objective : Analyze current process for post-market requirements under 505(O)(3)(A) Propose improvements to the current process for post-marketing requirements under 505(O)(3)(A)
      Tarek  Hammad, MD, PhD, MS, MSc, FISPE

      Lessons from Approval of a Drug to Treat Metastatic Merkel Cell Carcinoma

      Tarek Hammad, MD, PhD, MS, MSc, FISPE

      • Head, Signal Detection, Benefit-Risk Assessment, Global Drug Safety Innovation
      • EMD Serono, Inc., United States
      Tamy  Kim, PharmD

      FDA Perspective

      Tamy Kim, PharmD

      • Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER
      • FDA, United States
      Andrew  Robertson, JD, PhD

      Rethinking the Process for Post-Market Requirements

      Andrew Robertson, JD, PhD

      • Head, Global Regulatory Science and Policy, NA
      • Sanofi, United States