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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)
Jonathan P. Jarow, MD, PhD
Chief Medical Officer, ODE, CDRH, FDA, United States
FDA’s IND Safety Reporting Rule: Implementation and Impact
Marsha Millikan, RPh
Advisor, Expedited Reporting Global Patient Safety, Eli Lilly and Company, United States
The Advancing IND Safety Reporting Project of the Clinical Trials Transformation Initiative
Leann Fieldstad, PharmD
Global Solutions Executive, Watson for Patient Safety, IBM Watson Health, United States
A Global Perspective on IND Safety Reporting
Panel Discussion
, All Session Speakers, United States
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