Tsyabri: 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.
Designing 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
Optimizing 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
Suicidality: 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
Designing 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
Plotting a Strategy for the Best Benefit-Risk Ratio
John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics
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)
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