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Mandarin Oriental Washington D.C.

Jan 23, 2017 7:30 AM - Jan 25, 2017 3:15 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Pharmacovigilance and Risk Management Strategies Conference

Session 12: Hot Topic Panel

Session Chair(s)

Lisa Melanie Harinstein, PharmD

Lisa Melanie Harinstein, PharmD

Team Leader, Division of Pharmacovigilance, FDA

FDA, United States

Annette  Stemhagen, DrPH, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer

UBC, United States

Session Chair

Speaker(s)

Jonathan P. Jarow, MD, PhD

FDA’s IND Safety Reporting Rule: Implementation and Impact

Jonathan P. Jarow, MD, PhD

FDA, United States

Chief Medical Officer, ODE, CDRH

Marsha  Millikan, RPh

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

Leann  Fieldstad, PharmD

A Global Perspective on IND Safety Reporting

Leann Fieldstad, PharmD

IBM Watson Health, United States

Global Solutions Executive, Watson for Patient Safety

Panel  Discussion

Panel Discussion

All Session Speakers, United States

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