Andreas received a Master degree in Stats from the University of Dortmund. He initially worked as project leader for diabetes drugs. He has worked in pharmacovigilance and was involved in signal detection and spontaneous reports analysis. He is responsible for integrated analyses in the TA oncology.
Conny Berlin is Statistical Safety Leader at Novartis Pharma AG, where she is member of the Medical Safety Review Board. Her responsibilities include driving quantitative benefit-risk analyses, improving post-approval signal detection methods and ad-hoc consultancy for the safety management teams.
Dr. LaRee Tracy is a statistical team leader in the Office of Biostastistics, OTS, CDER, FDA. She leads a team of statisticians focused on quantitative safety and pharmacoepidemiology reviews and research. She has been at FDA for 10 years and involved in drug development for 17 years.
Ed Whalen, Pfizer Inc, United States
Description
This session will highlight statistical issues that arise during this review process, discussing approaches for screening, identification, quantification and presentation of individual adverse drug reactions for drug safety labeling.
Learning Objectives: Recognize the current quantitative approaches in labeling adverse drug reactions information Summarize relevant statistical issues of safety labeling Discuss the impact of novel approaches adverse drug reaction labeling.