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February 26-28, 2018
United States

Main Day 1

9:00 am - 9:45 am Defining the Future: Pharmacovigilance (PV) and What’s to Come

Valerie Perentesis - Vice President, Global Medical Safety Operations Janssen Pharmaceutical
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Valerie Perentesis

Vice President, Global Medical Safety Operations
Janssen Pharmaceutical

10:00 am - 10:45 am The New International Council for Harmonization (ICH) and What It Means for You

Sylvie Tomczyk - Vice President & Head Global PV & Risk Management Seqirus
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Sylvie Tomczyk

Vice President & Head Global PV & Risk Management
Seqirus

11:15 am - 12:00 pm Big Data and the Power of Proactive Pharmacovigilance

David Gao - Director-Physician Drug Safety, Pharmacovigilance AstraZeneca
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David Gao

Director-Physician Drug Safety, Pharmacovigilance
AstraZeneca

12:00 pm - 12:45 pm Outsourcing to Increase Efficiency and Cut your Costs

Judith Sills - Vice President and Head, Global Pharmacovigilance The Medicines Company
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Judith Sills

Vice President and Head, Global Pharmacovigilance
The Medicines Company

1:45 pm - 2:30 pm How to Interpret and Implement PV Activities in the Context of Externally Sponsored Research

Rodrigo Pimentel Ysla - Medical Director US Med Affairs - Patient Safety & Surveillance AstraZeneca
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Rodrigo Pimentel Ysla

Medical Director US Med Affairs - Patient Safety & Surveillance
AstraZeneca

2:30 pm - 3:15 pm Structured Assessment of Benefits and Risks in Drug Regulatory Decision-Making

Tzuyung Douglas Kou - Operational Chair, Risk Management Strategy Committee Bristol-Myers Squibb
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Tzuyung Douglas Kou

Operational Chair, Risk Management Strategy Committee
Bristol-Myers Squibb

3:45 pm - 4:30 pm Addressing the Rise in Inspections in 2016 to Zero in on Deficient Areas

Adrian Dana - Vice President, Global Patient Safety and Risk Management Alnylam
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Adrian Dana

Vice President, Global Patient Safety and Risk Management
Alnylam

4:30 pm - 5:15 pm Patient Perspective Improving the Drug Development Process

Christine McSherry - Rare Disease Advocate Duchenne Alliance

Christine McSherry

Rare Disease Advocate
Duchenne Alliance