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February 26-28, 2018
United States
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Main Day 1

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

Speaker:
Valerie Perentesis Vice President, Global Medical Safety Operations Janssen Pharmaceutical
Valerie Perentesis, Vice President, Global Medical Safety Operations at Janssen Pharmaceutical

Valerie Perentesis

Vice President, Global Medical Safety Operations
Janssen Pharmaceutical
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10:00 am - 10:45 am The New International Council for Harmonization (ICH) and What It Means for You

Speaker:
Sylvie Tomczyk Vice President & Head Global PV & Risk Management Seqirus
Sylvie Tomczyk, Vice President & Head Global PV & Risk Management at Seqirus

Sylvie Tomczyk

Vice President & Head Global PV & Risk Management
Seqirus
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11:15 am - 12:00 pm Big Data and the Power of Proactive Pharmacovigilance

Speaker:
David Gao Director-Physician Drug Safety, Pharmacovigilance AstraZeneca
David Gao, Director-Physician Drug Safety, Pharmacovigilance at AstraZeneca

David Gao

Director-Physician Drug Safety, Pharmacovigilance
AstraZeneca
See Bio

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

Speaker:
Judith Sills Vice President and Head, Global Pharmacovigilance The Medicines Company
Judith Sills, Vice President and Head, Global Pharmacovigilance at The Medicines Company

Judith Sills

Vice President and Head, Global Pharmacovigilance
The Medicines Company
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1:45 pm - 2:30 pm How to Interpret and Implement PV Activities in the Context of Externally Sponsored Research

Speaker:
Rodrigo Pimentel Ysla Medical Director US Med Affairs - Patient Safety & Surveillance AstraZeneca
Rodrigo Pimentel Ysla, Medical Director US Med Affairs - Patient Safety & Surveillance at AstraZeneca

Rodrigo Pimentel Ysla

Medical Director US Med Affairs - Patient Safety & Surveillance
AstraZeneca
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2:30 pm - 3:15 pm Structured Assessment of Benefits and Risks in Drug Regulatory Decision-Making

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

Tzuyung Douglas Kou

Operational Chair, Risk Management Strategy Committee
Bristol-Myers Squibb
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3:45 pm - 4:30 pm Addressing the Rise in Inspections in 2016 to Zero in on Deficient Areas

Speaker:
Adrian Dana Vice President, Global Patient Safety and Risk Management Alnylam
Adrian Dana, Vice President, Global Patient Safety and Risk Management at Alnylam

Adrian Dana

Vice President, Global Patient Safety and Risk Management
Alnylam
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4:30 pm - 5:15 pm Patient Perspective Improving the Drug Development Process

Speaker:
Christine McSherry Rare Disease Advocate Duchenne Alliance

Christine McSherry

Rare Disease Advocate
Duchenne Alliance
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