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DIA 2018 Global Annual Meeting

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


ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?

    Session Chair(s)
      Representative Invited

      Representative Invited

      • FDA, United States
    ICH Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” has the potential to be a paradigm changing document for post-approval changes. The guideline provides new tools to streamline and harmonize processes for post approval changes, through introduction of “established conditions”, “post approval change management plans (PACMPs)”, and product lifecycle management (PLCM) documents. Speakers in this session will introduce the concepts included in the ICH Q12 draft document and provide forward looking thoughts on the potential utilization. Following, a panel of international regulators will discuss the implementation plans and challenges .
    Learning Objective : Describe the elements for regulatory flexibility under ICH Q12 (e.g., established conditions, PACMPs) and their future potential for regulatory flexibility.
    Speaker(s)
      Representative Invited

      ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

      Representative Invited

      • FDA, United States
      Christine M. V. Moore, PhD

      Pathways for Decreasing Regulatory Burden Through ICH Q12

      Christine M. V. Moore, PhD

      • Global Head and Executive Director, GRACS CMC - Policy
      • Merck Research Laboratories, United States