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Session 12: Hot Topic Panel
Session Chair(s)
Lisa Melanie Harinstein, PharmD
Team Leader, Division of Pharmacovigilance, FDA
FDA, United States
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer
UBC, United States
Session Chair
Speaker(s)
FDA’s IND Safety Reporting Rule: Implementation and Impact
Jonathan P. Jarow, MD, PhD
FDA, United States
Chief Medical Officer, ODE, CDRH
The Advancing IND Safety Reporting Project of the Clinical Trials Transformation Initiative
Marsha Millikan, RPh
Eli Lilly and Company, United States
Advisor, Expedited Reporting Global Patient Safety
A Global Perspective on IND Safety Reporting
Leann Fieldstad, PharmD
IBM Watson Health, United States
Global Solutions Executive, Watson for Patient Safety
Panel Discussion
All Session Speakers, United States
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