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Pharmacovigilance and Risk Management Strategies Conference


Session 2: The New ICH

    Session Chair(s)
      William  Gregory, PhD

      William Gregory, PhD

      • Safety and Risk Management
      • Pfizer Inc, United States
    Since 1990, the International Conference on Harmonisation (ICH) has provided a consensus forum for drug regulators and the pharmaceutical industry to develop harmonized of scientific and technical requirements for registration of innovative pharmaceutical products. In October 2015, ICH announced organizational and process changes to expand formal participation of organizations beyond the EU, Japan, and the US. Further changes to the face of global biopharmaceutical product development were made in June 2017. This session will provide an overview of the current ICH. In addition, regulator and industry perspectives will be presented on global harmonization of a new topic, E-19 (optimization of safety data collection).
    Speaker(s)
      Amanda Marie Roache, MS

      Overview of the Current ICH

      Amanda Marie Roache, MS

      • Operations Research Analyst, OSP, CDER
      • FDA, United States
      Ellis  Unger, MD

      The New ICH E19 Guideline on Optimization of Safety Data Collection (in Development): Regulatory Perspective

      Ellis Unger, MD

      • Director, Office of Drug Evaluation I, OND, CDER
      • FDA, United States