Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 3: Patient-Centered Drug Development (2019)

Data Management & Informatics
Regulatory & Quality Sciences
Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 3: Patient-Centered Drug Development (2019)
Mladen Bozic, MS

VP & Head, Global Regulatory Policy and Intelligence, Takeda

Topics

  1. Introduction and Background
  2. Patient Role in Drug Approval - Food for Thought
  3. Policy Analysis: Pre-existing Policies in Patient-Focused Drug Development
  4. Patient Advocacy Organizations’ Role in Drug Development: Sarepta Case
  5. Impact Analysis
    1. Current Paradigm
    2. Positive Aspects
    3. Negative Aspects
  6. Conclusion References

Acknowledgement

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu  

Video Series

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