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Post-Approval Drug Safety Strategies

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

FEATURED PRESENTATIONS

Carmen_BozicTsyabri: Practical case studies in REMS, EU RMPs; unifying the European RMP with the FDA REMS

Carmen Bozic, M.D., Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec Inc.

 

 

 

 

Ralph_DAgostinoDesigning and Analyzing a Randomized Control Trial for Detecting and Understanding Safety

Ralph B. D’Agostino Sr., Ph.D., Professor of Mathematics, Statistics, and Public Health, Boston University

 

 

 

 

Jill_RobinsonOptimizing the Allocation of an Organization’s Product Safety and Risk Management

Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth

 

 

 

 

Kelly_PosnerSuicidality: Defining and Studying Suicidality in CNS and Beyond: What Do We Really Know and Where are We Going?

Kelly Posner, Ph.D., Principal Investigator, Columbia/FDA Classification Project for Drug Safety Analyses, Director of the Center for Suicide Risk Assessment, Columbia University

 

 

 

 

Nicolle_GattoDesigning an Epidemiologic Research Strategy to Support Risk Management

Nicolle Gatto, Ph.D., Senior Director, Oncology BU Group Head, Epidemiology, Safety and Risk Management, Pfizer Inc

 

 

 

 

John_FergusonPlotting a Strategy for the Best Benefit-Risk Ratio

John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics

 

 

 

 

Two Opening Workshops

Pragmatic Approaches to FDAAA: A Decision Tree Approach to Successful REMS Creation and Risk Assessement Studies

Hosted by United BioSource Corporation (UBC)

Practical Approaches to Lifecycle Signal Detection

Hosted by Drug Safety Alliance (DSA)

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Complimentary Whitepaper

Fundamentals of Drug Safety Strategies 

Provided by ClinQuest


For questions or suggestions about the meeting, please contact:
Micah Lieberman
Executive Director, Conferences
Pharmaceutical Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@pharmaseries.com

For exhibit, partnering and sponsorship information, please contact:
Arnold Wolfson
Business Development Manager
Pharmaceutical Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5431
E: awolfson@healthtech.com

For media and association partnerships, please contact:
James Prudhomme
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5459
E: jprudhomme@healthtech.com


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